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SpectraQuattro Pulsed Light System

by Amjet Distribution, LLC

510(k) K052336

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052336 Date11 Oct 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEX
Device Class
Class II
Regulation
21 CFR Part 878.4810
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SpectraQuattro Pulsed Light System is a compact, self-contained phototherapeutic device that delivers pulsed light (300nm-1400nm) via a handpiece to specific treatment sites. It is generally indicated for the treatment of dermatological conditions including vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris. The system includes a control console, power supply, cooling system, and footswitch.

The SpectraQuattro Pulsed Light System uses interchangeable light spectrum filters to target specific treatment areas. It is substantially equivalent to the Cooltouch PRIMA. The device received FDA 510(k) clearance (K052336) on 2005-10-11 after a 46-day FDA review. The product code is GEX and it was reviewed by the General and Plastic Surgery advisory committee.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SpectraQuattro Pulsed Light System used for?

    The SpectraQuattro is a compact, self-contained phototherapeutic device that delivers pulsed light via a handpiece to specific treatment sites. It is generally indicated for treating dermatological conditions including vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.

  • How is the SpectraQuattro Pulsed Light System supplied?

    The system includes a control console, power supply, cooling system, and footswitch. It uses interchangeable light spectrum filters to target specific treatment areas, making it versatile for various dermatological applications. The device is manufactured by Amjet Distribution, LLC.

  • What is the regulatory status of the SpectraQuattro Pulsed Light System?

    The SpectraQuattro Pulsed Light System received FDA 510(k) clearance (K052336) on October 11, 2005, after a 46-day FDA review. It is substantially equivalent to the Cooltouch PRIMA and was reviewed by the General and Plastic Surgery advisory committee with product code GEX.

  • What are the key features of the SpectraQuattro Pulsed Light System?

    The SpectraQuattro is a compact, self-contained device that delivers pulsed light in the range of 300nm-1400nm. It features interchangeable light spectrum filters for targeting specific treatment areas and includes a control console, power supply, cooling system, and footswitch for operation.