Manufacturer
Raja Trading Company, Inc.OxyLight 2.0
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
1Oxylight
K202175 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K202175 as a predicate