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Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family

Shaser, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

Shaser, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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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

Predicate devices

2

K142924 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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