# K041323: Pulsed Light Therapy System, Model Prima

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Nov 17, 2004 after 183 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) New Star Lasers, Inc. UV-300 Pulsed Light Therapy System: named in the summary without a submission number
- (no number) Radiancy, Inc. SkinStation Pulsed Light System: named in the summary without a submission number
- (no number) Palomar Estelux Pulsed Light Therapy System: named in the summary without a submission number

## Most influential descendants
- K052336: Spectraquattro Pulsed Light System (2005), 0 descendants of its own

## Indications for use
The CoolTouch PRIMA Pulsed Light Therapy System is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis, vascular lesions, rosacea, hemangiomas, leg veins, hair removal, tattoos, pigmented lesions, lentigenes, and mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K041323
Methodology: https://510kreport.com/methodology