Manufacturer
Shaser, Inc.Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
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
- K142924
- Device name
- Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
- Company
- Shaser, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-10-08
- Decision date
- 2015-02-13
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for: - The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Intended Use
Shaser Skin Beauty SkinREJUV Intense Pulsed Light System Family is a prescription home use device intended to provide phototherapeutic light to the body. It is specifically intended for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
Device Description
Shaser Skin Beauty SkinREJUVTM Intense Pulsed Light System Family devices are prescription home use, light-based skin care systems. The family includes an AC mains powered and battery powered version of the same device. The Principle of Operation is selective photothermolysis and the Mechanism of Action is to lighten or resolve lesions using light for preferentially heating. Emission activation is by finger switch. Device includes a limited life treatment head. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.
Summary parsed at:2026-06-01 06:10:26 UTC