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OxyLight 2.0

Raja Trading Company, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

Raja Trading Company, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K202175
Device name
OxyLight 2.0
Company
Raja Trading Company, Inc.
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-08-04
Decision date
2021-12-02
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 2.0 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 2.0 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 subject device Oxylight 2.0 is a skin therapy system that was modified from the existing device. It includes LED technology for various treatments and microdermabrasion capabilities.

Summary parsed at:2026-06-01 05:41:29 UTC

Predicate devices

1

K202175 references 1 predicate/reference device

Cited as predicate

0

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