Oxylight

Raja Trading Company, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K200104
Device name
Oxylight
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-01-17
Decision date
2020-06-04
Submission type
Traditional
Technology type
LED(AI inferred)
Clinical applications
Acne treatmentVascular treatmentSkin resurfacingSkin tightening
Primary application
Acne treatment
Classification source
AI classified

Indications for Use

The Oxylight is intended for dermatological use by physicians and healthcare professionals for the following:

LED Technology is intended for:
- Blue LED – 465nm – to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
- Red LED 625nm - for treatment of superficial, benign vascular and pigmented lesions.
- Yellow LED 590nm - treatment of periorbital wrinkles and rhytides.

Microdermabrasion is intended for exfoliation of the skin.

Oxygen spray is intended to refresh the skin.

Intended Use

The Oxylight is intended for dermatological use by physicians and healthcare professionals for the following: LED Technology is intended for: -Blue LED – 465nm – to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red LED 625nm- for treatment of superficial, benign vascular and pigmented lesions. -Yellow LED 590nm - treatment of periorbital wrinkles and rhytides. Microdermabrasion is intended for exfoliation of the skin. Oxygen spray is intended to refresh the skin.

Device Description

The Oxylight system is a skin therapy system that uses three major modalities delivered by different attachments powered from a single energy source and operated from a universal control unit. The treatments include, LED Light Panel Therapy (Class 2), Microdermabrasion (Class 1, 510k exempt) and Oxygen Spray. The Oxygen Spray is delivered through the same panel used for LED light therapy and separate handpieces.

Summary parsed at:2026-06-01 05:47:38 UTC

Predicate devices

4

K200104 references 4 predicate/reference devices

Cited as predicate

4

4 submissions cite K200104 as a predicate