Manufacturer
Raja Trading Company, Inc.Oxylight
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200104
- Device name
- Oxylight
- 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
- 2020-01-17
- 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
4Cited as predicate
4OxyLight 2.0
LED Light Therapy Device, KN-7000L
Phototherapy System (OL-PDT950)
Photon Therapy Apparatus (BL-10)
4 submissions cite K200104 as a predicate
