# K052336: Spectraquattro Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Amjet Distribution, LLC
- Decided: Oct 11, 2005 after 46 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: 6 generations back to K910422 (1992). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030897: Skinstation, Radiancy (Israel), Ltd. (2003)
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 1.
- K051268: Radiance Acne System with Cleartouch Light Unit, Radiancy, Ltd. (2005) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K041323: Pulsed Light Therapy System, Model Prima, New Star Lasers, Inc. (2004) Summary page 1.

## Indications for use
The SpectraQuattro TM Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro TM Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris. SpectraQuattro TM comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended: Light Spectrum Filter — Indications 410-1200 — Mild to moderate inflammatory and pustular inflarmnatory acne vulgaris 530-1200 — pigmented lesions 560-1200 — lentigenes 585-1200 — Vascular lesions, rosacea, hemangiomas, leg veins 640-1200 — Hair removal

Source page: https://510kreport.com/device/K052336
Methodology: https://510kreport.com/methodology