# K142924: Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family

- Pathway: 510(k) (Traditional)
- Applicant: Shaser, Inc.
- Decided: Feb 13, 2015 after 128 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K950019 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141583: Shaser Skin Beauty Intense Pulsed Light System Family, Shaser, Inc. (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K070833: Atlantis Abutment for Astra Implant, Atlantis Components, Inc. (2007). Our reading of the summary gave K070833, FDA’s number for Atlantis Abutment for Astra Implant (Atlantis Components, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sciton Profile Multi-Platform System”. Kept off the family tree. Summary page 4.

## 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, rosecea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.

Source page: https://510kreport.com/device/K142924
Methodology: https://510kreport.com/methodology