SGS Biocompatibility Testing Report

SGS, the world's leading inspection, verification, testing and certification company, has independently tested the LIGHT WELLNESS LED Mask for biocompatibility under ISO 10993 standards. All three tests passed with the highest safety ratings.

Test Report Summary

Field	Value
Test Laboratory	SGS-CSTC Standards Technical Services Co., Ltd.
Report Number	GZCPCH221006835E
Test Standard	ISO 10993 (Biological evaluation of medical devices)
Test Item	LIGHT WELLNESS LED Mask (Silicone body + PET eye shields)
Report Date	October 2022

Test 1: Cytotoxicity (ISO 10993-5)

This test evaluates whether the device materials are toxic to living cells. Extracts of the device materials were applied to L929 mouse fibroblast cells in culture.

Parameter	Result
Test Method	MTT assay (ISO 10993-5:2009)
Cell Viability	94.13%
Cytotoxicity Grade	Grade 0 (Non-cytotoxic)
Pass Criterion	Cell viability > 70% = Non-cytotoxic (Grade 0-1)
Result	PASS

Interpretation: At 94.13% cell viability (well above the 70% threshold), the device materials showed essentially no toxicity to living cells. This confirms the silicone body and PET eye shields are safe for prolonged skin contact.

Test 2: Dermal Irritation (ISO 10993-10)

This test evaluates whether the device causes skin irritation. Extracts were applied to the skin of animal models and observed for erythema (redness) and edema (swelling) reactions.

Parameter	Result
Test Method	Primary skin irritation test (ISO 10993-10:2010)
Primary Irritation Index (PII)	0.0
Irritation Category	Negligible / No irritation
Pass Criterion	PII < 0.5 = Negligible irritation
Result	PASS

Interpretation: A Primary Irritation Index of 0.0 means no observable skin irritation. The device can be worn directly against the skin for the full treatment duration without causing redness, swelling, or discomfort.

Test 3: Skin Sensitization (ISO 10993-10)

This test evaluates whether the device causes allergic sensitization — an immune response that develops over repeated exposure. The test uses the maximization method to evaluate potential allergenic effects.

Parameter	Result
Test Method	Guinea pig maximization test (ISO 10993-10:2010)
Sensitization Rate	0%
Sensitization Category	Non-sensitizer (Grade 0)
Pass Criterion	Sensitization rate = 0% = Non-sensitizer
Result	PASS

Interpretation: A 0% sensitization rate means the device materials do not cause allergic reactions, even with repeated, long-term skin contact. This is important for a device designed for regular use over months and years.

Why SGS Biocompatibility Matters

SGS is one of the world's most respected third-party testing organizations, with accreditations from over 40 national authorities. Their biocompatibility testing follows ISO 10993 — the international standard for evaluating the biological safety of medical devices.

The three tests conducted (cytotoxicity, irritation, sensitization) represent the core biocompatibility requirements for surface-contacting medical devices under ISO 10993-1. Passing all three with the highest ratings means the LIGHT WELLNESS LED Mask is biologically safe for its intended use.

These tests were required for our FDA 510(k) clearance and are part of the safety documentation submitted to the FDA. The full SGS report (GZCPCH221006835E) is available upon request.