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Packaging Information

Declaration of Conformity

Legal Manufacturer:	Iridex Corporation 1212 Terra Bella Avenue Mountain View CA 94043-1824, USA www.iridex.com
European Authorized Representative:	Emergo Europe B.V. Westervoortsedijk 60 6827 AT Arnhem The Netherlands
Packaging Configuration:	See Table 1, Table 2, Table 3, and Table 4
Packaging Description & Identification:	See Table 5, Table 6, Table 7, and Table 8
Applicable Union Legislation:	Regulation (EU) 2025/40
Conformity Assessment:	Article 38, Article 39 and Annex VII (Module A - Internal Production Control), including technical documentation
Relevant Standards and Specifications:	There are no additional current common specifications or harmonized standards to which conformity is declared
Notified Body:	Not Applicable (self-assessment/internal production control)

This declaration of conformity is issued under the sole responsibility of Iridex Corporation in compliance with Annex VIII of the Regulation (EU) 2025/40. We hereby declare that the packaging identification and its descriptions specified in the attached list meet the provisions of Regulation (EU) 2025/40.

Signed for and on behalf of: Iridex Corporation	8/21/2026 \| 3:16 PM PDT Date of Issue
Name: Bill Hyatt Function: Director of Regulatory Affairs	Mountain View, CA 94043 U.S.A. Place of Issue

Table 1: Laser Console and Capital Equipment Packaging Configuration

No.	Packaging Configuration ID	Product Configuration Description	Details of Included Components
1.	LC-01	Base Configuration consisting of: Laser Console and Standard Wired Footswitch	Laser console packaged together with the standard footswitch
2.	LC-02	Base Configuration + Wireless Footswitch	Base configuration packaged with a wireless footswitch
3.	LC-03	Base Configuration + LIO	Base configuration packaged with Laser Indirect Ophthalmoscope (LIO)
4.	LC-04	Base Configuration + LIO + SLA	Base configuration packaged with LIO and Slit Lamp Adapter (SLA)
5.	LC-05	Base Configuration + SLA	Base configuration packaged with Slit Lamp Adapter (SLA)
6.	LC-06	Base Configuration + TxCell	Base configuration packaged with TxCell Scanning Delivery System
7.	LC-07	Base Configuration + TxCell + LIO	Base configuration packaged with TxCell System and LIO
8.	LC-08	Base Configuration + LIO + SLA + TxCell	Base configuration packaged with a LIO, SLA and TxCell
9.	LC-09	Base Configuration + LIO + SLA + TxCell + Wireless Footswitch	Base configuration packaged with a LIO, SLA, TxCell and wireless footswitch
10.	LC-10	Accessories added to any of the above configurations (see accessories configurations)	The following accessories may be packaged with any LC-01 through LC-09, but these do not change the packaging configuration that they are shipped in. For accessory specific packaging material information refer to Table 3 • Remote Control (IQ Family only) • Safety glasses • OMA • ESF • MLT Lens with Flange • Dust Cover, GL/GLx/TX • Dust Cover, SL/SLx/DioVet • Dust cover for IQ532/IQ577 • Assy. Illum. Adapter (ea) (Alcon® Accurus® and Greishaber®) • Assy. Illum. Adapter Thread Connect (Photon) (ea) (Synergetics® Photon™) • Assy. Illum. Adapter - Friction Fit (ea) (D.O.R.C. BrightStar) • Assy. Illum. Adapter (ea) (Bausch & Lomb® Stellaris®) • Shunted SmartKey • Adapter Plate Haag Streit BQ

Table 2: Probes Packaging Configuration

No.	Packaging Configuration ID	Product Configuration Description	Details of Included Components
1.	PRB-01	Base Configuration consisting of: Standard Box (White) of 6 Probes	6x Individually packaged Probe Delivery Devices
2.	PRB-02	Pack of 1 or 2 Base Configuration in a Box	Outer Shipping Box
3.	PRB-03	Pack of 3 Base Configuration in a Box	Outer Shipping Box
4.	PRB-04	Pack of 5 Base Configuration in a Box	Outer Shipping Box
5.	PRB-05	Pack of 8 Base Configuration in a Box	Outer Shipping Box
6.	PRB-06	Japan only: 10 Cell Probe Box + Dividers	Outer Shipping Box for Japan only
7.	PRB-07	Single, Probe, Sterile	Individually supplied probe in Tyvek pouch packaged in bubblewrap. Note: The sterile Tyvek pouch, which is primary packaging, is excluded from the minimum recycled content requirements of Article 7(1) and (2) where it qualifies as contact-sensitive plastic packaging of a medical device covered by Regulation (EU) 2017/745, in accordance with Article 7(4)(b).

Table 3: Accessories Packaging Configuration

No.	Packaging Configuration ID	Product Configuration Description	Details of Included Components
1.	ACC-01	Remote Control (IQ Family only)	Packaged in a bubble wrap
2.	ACC-02	Operating Microscope Adapter (OMA)	OMA packaged in a Box and Foam
3.	ACC-03	Eye Safety Filter (ESF)	ESF packaged in a Box + Foam Set
4.	ACC-04	Safety Glasses	Case (Re-usable, exempt)
5.	ACC-05	Miscellaneous Accessories: • Dust Cover, GL/GLx/TX • Dust Cover, SL/SLx/DioVet • Dust Cover for IQ532/IQ577 • Assy. Illum. Adapter (ea) (Alcon® Accurus® and Greishaber®) • Assy. Illum. Adapter Thread Connect (Photon) (ea) (Synergetics® Photon™) • Assy. Illum. Adapter - Friction Fit (ea) (D.O.R.C. BrightStar) • Assy. Illum. Adapter (ea) (Bausch & Lomb® Stellaris®) • Shunted SmartKey • Adapter Plate Haag Streit BQ	Various polybags and/or Bubble wrap

Table 4: Pascal Synthesis Packaging Configuration

No.	Packaging Configuration ID	Product Configuration Description	Details of Included Components
1.	PAS-01	Shipping box including Accessories	Shipping box for Synthesis and various accessories consisting of various system components
2.	PAS-02	PAS-01 + Pascal LIO	PAS-01 packaged with Pascal LIO

For the purposes of this Declaration of Conformity, following are the definitions of the packaging identifications:

Primary: The primary packaging encloses or supports an individual product unit. This consists of contact-sensitive probe pouches (exempt from PPWR), protective foam inserts, and various polybags or bubble wraps utilized to wrap, isolate, and protect accompanying accessories and miscellaneous parts within the primary sales unit.
Secondary: The secondary packaging is used to group multiple sales units together. This consists of white probe boxes used to group six individual probe pouches.
Tertiary: Tertiary packaging is utilized to facilitate the handling and transport of primary units or secondary packaging configurations. This consists of outer shipping boxes, heavy-duty corrugated cartons, and pallets to prevent physical handling and transport damage.

Table 5: Laser Console and Capital Equipment Packaging Identification

No.	Packaging Configuration ID	Component Specification (CS)	Packaging Description	Specification	Packaging Identification (Primary or Secondary or Tertiary)	Packaging Supplier	Supplier PN	Material
Shared Packaging Material: Common to LC-01 through LC-09
IQ 532/577 and Cyclo G6 Laser Console Products
1.	LC-01 through LC-09	65561	Shipping Box, IQ Family and Cyclo G6	Dimensions (LWH): 18" × 18" × 24”	Tertiary	Stephen Gould	65561	Cardboard, Double Wall Corrugated 275BC
2.	LC-01 through LC-09	65560	Foam Set, IQ Family and Cyclo G6	18” × 18” (includes the 03 cutouts) Single large rectangular cutout total height 11 ¾” The 18” × 18” cap with the stepped rectangular frame cutout A solid 2 ¼” thick foam blocking pad A solid 1” thick base pad acting as the floor	Primary	Stephen Gould	65560	1480CHAR
OcuLight GL/TX/SLx/SL Laser Console Products
3.	LC-01 through LC-09	87337	Shipping Box, Half Non-Carry All Box, GL/TX/SL/SLx	Dimensions (LWH): 21 1⁄8” × 17 1⁄4” × 11 5⁄8”	Tertiary	Container Consulting Services (CCS)	87337	Cardboard, Double Wall Corrugated 275BC
4.	LC-01 through LC-09	12836	Foam Set, Non-Carry All, GL/TX/SL/SLx	Variable	Primary	Stephen Gould	12836	Various
5.	LC-01 through LC-09	11923	Box Scored Pad, Footswitch, Accessory (Non-Joined Divider for box PN 87337)	Dimensions: 11.63” × 57.5”	Primary	Stephen Gould	11923	Cardboard, Double Wall Corrugated 275BC
Packaging Material: Specific to TxCell, LIO, SLA, or Wireless Footswitch
TxCell Scanning Laser Delivery System
6.	LC-06 through LC-09	70366	TxCell Foam and Shipping Box Set	Box Dimensions (LWH): 22” × 17” × 13” Foam a) Laser Pack Assembly Foam Thicknesses: Item 2: 1 in. Item 3: 2 in. Item 4: 1 in. Item 5: 2 in. Item 6: 1 in. b) Main Assembly Foam Thicknesses: Item 1: 1 in. Item 2: 2.38 in. Item 3: 1 in. Item 5: 2 in. Item 6: 2 in. Item 7: 2 in. Item 8: 4 in.	Shipping Box: Tertiary Foam: Primary	Stephen Gould	70366	Box: Double Wall Corrugated Cardboard, 275C Foam: Urethane 1.5PCF, IFD 50
7.	LC-06 through LC-09	88154	Anti-Static Poly Bag 4 mil (TxCell SLA)	Dimensions: 8” × 16”	Primary	U-Line	S-6965	Linear LDPE
8.	LC-06 through LC-09	88155	Anti-Static, 4 mil Poly Bag (TxCell Control Box)	Dimensions: 16” × 20”	Primary	U-Line	S-5255	Linear LDPE
Laser Indirect Ophthalmoscope (LIO)
9.	LC-03, LC-04, LC-07, LC-08, LC-09	87306	Shipping Box, 8 Pack Probe, LIO and OMA	Dimensions (LWH): 21 1⁄2" × 11 1⁄2" × 16 5⁄8”	Tertiary	CCS	87306	Double Wall Corrugated Cardboard, 275C
10.	LC-03, LC-04, LC-07, LC-08, LC-09	13143	Shipping Foam for 13142 Box – Side Entry Box	Dimensions (LWH): 21.38" × 11.38" × 5.25”	Primary	Stephen Gould	13143	Expanded Polypropylene (EPP) 1.3 PCF
Slit Lamp Adapters (SLA)
11.	LC-04, LC-05, LC-08, LC-09	87306	Shipping Box, 8 Pack Probe, Double Corrugated	Dimensions (LWH): 21 1⁄2" × 11 1⁄2" × 16 5⁄8”	Tertiary	CCS	87306	Double Wall Corrugated Cardboard, 275C
12.	LC-04, LC-05, LC-08, LC-09	11916	Carry All, SLA Foam Top and Bottom	Dimensions (LWH): 17.75” × 12.63” × 4.51”	Primary	Stephen Gould	11916	P65 Charcoal material
13.	LC-04, LC-05, LC-08, LC-09	31140	Box, Shipping, Symphony SLA	Dimensions (LWH): 24 1⁄4" × 14 3⁄4" × 7 7⁄8”	Tertiary	CCS	31140	Double Wall Corrugated Cardboard, 275C
14.	LC-04, LC-05, LC-08, LC-09	31141	Shipping Foam for 31140 Box – Symphony Box	Top Lid Enclosure Dimensions (LWH): 21 3⁄4" × 14 1⁄2" × 1 3⁄4" Bottom Base Enclosure Dimensions (LWH): 21 1⁄2" × 14 1⁄2" × 3 1⁄2"	Primary	Stephen Gould	31141	N95 CHAR
Wireless Footswitch
15.	LC-02, LC-09	N/A (Procured directly from Supplier)	Box, Wireless Footswitch	9” × 9" × 7”	Primary	U-Line	S-4596	Cardboard, Corrugated Boxes

Table 6: Iridex Probe Delivery Devices Packaging Identification

No.	Packaging Configuration ID	Component Specification (CS)	Packaging Description	Specification	Packaging Identification	Packaging Supplier	Supplier PN	Material
1.	(Exempt) PRB-01 through PRB-07	• 10370 • 10371	Pouch, Tyvek	Dimensions: • 8” × 12” • 10” × 15”	Primary (contact-sensitive)	Oliver Healthcare	• 10370 • 10371	Pouch uses MDT1073TT Tyvek for base material and is sealed with MRM4820PU Film
2.	PRB-01	15462	Box, White, Small Six pack Box	Dimensions (LWH): 15.25” × 10.00” × 3.00”	Secondary	• Stephen Gould/ • CCS	15462	0.024 THK. CANDESCE C1S SBS
3.	PRB-01	11822	Box, White, Large Six pack Box	Dimensions (LWH): 15.25” × 10.19” × 1.94”	Secondary	• Stephen Gould/ • CCS	11822	0.024 THK. CANDESCE C1S SBS
4.	PRB-02	13159	Shipping Box, SLA/LIO/Misc (2 Probe Box)	Dimensions (LWH): 17 3⁄4" × 12 1⁄2" × 6 1⁄8”	Tertiary	Stephen Gould	13159	Double Wall Corrugated Cardboard, 275BC
5.	PRB-02	87291	1 or 2 Probe VARI Depth	Dimensions (LWH): 15 1⁄2" × 10 1⁄8" × 6 1⁄2"	Tertiary	CCS	87291	Single Wall Corrugated Cardboard, 200C
6.	PRB-03	87288	3 Pack Probe Outer Box	Dimensions (LWH): 17" × 13" × 11"	Tertiary	CCS	87288	Double Wall Corrugated Cardboard, 275BC
7.	PRB-04	87290	5 Pack Probe Outer Box	Dimensions (LWH): 10 7⁄8" × 10 7⁄8" × 15 3⁄8"	Tertiary	CCS	87290	Double Wall Corrugated Cardboard, 275BC
8.	PRB-05	87306	Box, 8 Pack Probe, Double Corrugated	Dimensions (LWH): 21 1⁄2" × 11 1⁄2" × 16 5⁄8”	Tertiary	CCS	87306	Double Wall Corrugated Cardboard, 275BC
9.	PRB-06	87338	Probe Box,10 Cell with Dividers (For JAPAN Only)	Dimensions (LWH): 23 1⁄4” × 18 1⁄2” × 18” + Dividers	Tertiary	CCS	87338	Single Wall Corrugated Cardboard, 275C
10.	PRB-07	N/A	Single, Probe, Sterile	Individual single probe bubble wrapped	Primary	U-Line	S-2875P	Nylon/LDPE

Table 7: Accessory Packaging Identification

No.	Packaging Configuration ID	Component Specification (CS)	Packaging Description	Specification	Packaging Identification (Primary or Secondary or Tertiary)	Packaging Supplier	Supplier PN	Material
Remote Control
1.	ACC-01	N/A	Anti-Static Bubble Wrap, Strong Bubble Roll 5⁄16"	Dimensions: 24" × 375', Perforated	Primary	U-Line	S-2875P	Nylon/LDPE
OMA
2.	ACC-02	87306	Shipping Box, 8 Pack Probe, LIO and OMA	Dimensions (LWH): 21 1⁄2" × 11 1⁄2" × 16 5⁄8”	Tertiary	CCS	87306	Double Wall Corrugated Cardboard, 275C
3.	ACC-02	13143	Shipping Foam for 13142 Box – Side Entry Box	Dimensions (LWH): 21.38" × 11.38" × 5.25”	Primary	Stephen Gould	13143	Expanded Polypropylene (EPP) 1.3 PCF
ESF
4.	ACC-03	32828	Packaging, Fixed Eye ESF, Lens box assembly with Foam	Dimensions (LWH): 5" × 4.75" × 1.5”	Shipping Box: Tertiary Foam: Primary	Stephen Gould	32828	Box: Single Wall Corrugated Cardboard, 200C Foam: PE 1.5PCF Black
5.	ACC-03	30606	Box, Shipping, 2 Position ESF	Dimensions (LWH): 11 1⁄4" × 8 3⁄4" × 3”	Tertiary	Stephen Gould	30606	Box: Single Wall Corrugated Cardboard, 200C
6.	ACC-03	30607	Foam Insert, 2 Position ESF	Dimensions (Top & Bottom, LWH): 11 1⁄4" × 8 3⁄4" × .625”	Primary	Stephen Gould	30607	Polyurethane
Safety Glasses (Re-usable Case, Exempt)
7.	ACC-04	N/A	Glasses Packed in Protective Case	Re-usable Case	N/A	NoIR LaserShield	Various	N/A
Miscellaneous
8.	ACC-05	45106	Reclosable Bags 4 Mil	Inside W × L: 8 × 10"	Primary	U-Line	S-1713	Polyethylene Film
9.	ACC-05	11914	Self-Seal Bubble Bags	Inside W × L: 4 × 5 1⁄2"	Primary	U-Line	S-680	Nylon/LDPE Adhesive: Rubber based
10.	ACC-05	11925	Polybag 2 Mil	Dimensions: 24" × 30"	Primary	U-Line	Various	Linear LDPE
11.	ACC-05	11926	Polybag 2 Mil	Dimensions: 9" × 15"	Primary	U-Line	Various	Linear LDPE
12.	ACC-05	87550	Polybag 2 Mil	Dimensions: 8” × 8”	Primary	U-Line	S-1337	LDPE
13.	ACC-05	N/A	Anti-Static Bubble Wrap, Strong Bubble Roll 5⁄16"	Dimensions: 24" × 375', Perforated	Primary	U-Line	S-2875P	Nylon/LDPE
14.	ACC-05	16100	Anti-Static Self Seal Bubble Bag	Dimensions: 4 × 5 ½	Primary	U-Line	S-500	LDPE with a nylon layer Adhesive: Rubber based
15.	ACC-05	82391	Bag, Pink, Anti-Static, Polybags, 6 Mil	Dimensions: 24" × 36"	Primary	National Bag Company, Inc.	90610C6	Various

Table 8: Pascal Synthesis Packaging Identification

No.

Packaging Configuration ID

Component Specification (CS)

Packaging Description

Specification

Packaging Identification
(Primary or Secondary or Tertiary)

Packaging Supplier

Supplier PN

Material

PAS-01

SA-06430

Assembly, Shipping Box Synthesis III PA-04 Complete

Comprises of following shipping boxes and a pallet runner:

a) SS-06164, Shipping Box, Synthesis 3

Cardboard Boxes:

Item -02 (275# BC Flute Kraft Box): 19.25 × 32.25 × 22.5
Item -03 (275# BC Flute Kraft Box): 14.125 × 18.25 × 19.5

Left & Center-Left Stack (Foam)

Item -19 (1.2# PLM Green): 0.88(ex) × 16.75 × 18.5
Item -18 (1.2# PLM Green): 4(ex) × 16.75 × 18.5
Item -17 (P45 Gray): 2 × 12.5 × 14.75
Item -16 (P45 Gray): 1 × 12 × 15
Item -15 (P45 Gray): 2 × 7 Dia (Circular block)
Item -14 (P45 Grey): 18.5 × 17 × 15.875
Item -13 (1.2# PLM Green - Qty 2): 1.88(ex) × 16.75 × 18.5

Right & Far-Right Stack (Foam)

Item -12 (1.2# PLM Green): 1.88(ex) × 13.75 × 17.5
Item -11 (1.7# EPE Blue): 17.875 × 13.75 × 13.875
Item -10 (1.7# EPE Blue): 17.875 × 13.75 × 13.875

b) SS-06190, Shipping Box, Synthesis Accessories, Small Dimensions:

Box:

Item -04 (275# BC Flute Kraft Cardboard Box): 20.25 × 19.25 × 14.125

Foam Components:

Item -23 (1.2# PLM Green Pad): 0.88(ex) × 19.25 × 20.25
Item -22 (1.2# PLM Green Open-Top Liner Assembly): 14.125 × 19.25 × 20.25
Item -21 (1480 Blue Pad): 1 × 13 × 16
Item -20 (1.2# PLM Green Blocks - Qty 2): 1.88 (ex) × 4 × 12

c) SS-06299, 2-Honeycomb Pallet Runner, 48 x 6 x 4

Shipping Box: Tertiary

Foam: Primary

Stephen Gould

SA-06430

Kraft Cardboard Boxes

P45 Charcoal Polyurethane / 1480Blue
1.2#Polylam Green / 1.7# Expanded Polyethylene Blue

PAS-02

SS-06192

Box, Shipping, PASCAL LIO

SS-06192 consists of following packaging components with dimensions (LWH):

LIO Kit Carton, SS-06199: 19.80" × 16.26" × 12.85
LIO Kit Base Tray, SS-06200: 10.16" × 5.91" × 4.96”
LIO Kit Creased Board, SS-06201: 19.80" × 16.26" × 12.85”
LIO Kit Base Tray 1, SS-06202: 14.49" × 15.55" × 5.63”
LIO Kit Pad, SS-06203: 15.55" × 14.13" × 0.51”
Top Cap, Pascal LIO Kit, SS-06204: 18.90" × 15.55" × 6.57”

Shipping Box: Tertiary

Foam: Primary

Keeler Ltd

1205-P-5031

Carton: Cardboard corrugated

Tray, Board, Pad and Cap: Stratocell PE Foam White