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Spectragenics ATS-1

by Spectragenics, Inc.

510(k) K060567

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 NumberK060567 Date28 Apr 2006ClearedStatusActive

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  • Withdrawn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 Spectragenics ATS-1 is a device indicated to treat dermatological conditions, specifically moderate inflammatory acne vulgaris. It is substantially equivalent to predicate devices in treating these conditions.

The device is authorized under FDA 510(k) clearance with number K060567, received on March 3, 2006, and decided on April 28, 2006. It is manufactured by Spectragenics, Inc. in Pleasanton, California. No information regarding sterility, single-use or reusable status, MRI safety, or sizes is provided in the data.

Other devices from Spectragenics, Inc.

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 SPECTRAGENICS ATS-1 device used for?

    The SPECTRAGENICS ATS-1 is indicated to treat dermatological conditions, specifically moderate inflammatory acne vulgaris. It is designed to address this common skin condition through its therapeutic mechanism.

  • What is the regulatory status of the SPECTRAGENICS ATS-1?

    The device is authorized under FDA 510(k) clearance with number K060567, received on March 3, 2006, and decided on April 28, 2006. It is classified as substantially equivalent to predicate devices for treating moderate inflammatory acne vulgaris.

  • Who manufactures the SPECTRAGENICS ATS-1 and where is it produced?

    The SPECTRAGENICS ATS-1 is manufactured by Spectragenics, Inc. located at 5880 W. Las Positas Blvd., Suite 52, Pleasanton, California 94588. The company is responsible for production and quality control of the device.

  • Is the SPECTRAGENICS ATS-1 a single-use or reusable device?

    The device data does not specify whether the SPECTRAGENICS ATS-1 is designed for single-use or multiple uses. No information regarding sterility or reuse potential is provided in the available documentation.