# K060567: Spectragenics Ats-1

- Pathway: 510(k) (Traditional)
- Applicant: Spectragenics, Inc.
- Decided: Apr 28, 2006 after 56 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: 7 generations back to K910422 (1992). 59 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013623: Clearlight Phototheraphy System, Model CL 420, Curelight, Ltd. (2002) Summary page 1.
- K030338: Iclear Phototherapy System, Model FGCM0002, Curelight, Ltd. (2003) Summary page 1.
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 2.
- K051268: Radiance Acne System with Cleartouch Light Unit, Radiancy, Ltd. (2005) Summary page 2.
- K032205: Radiancy Acne System with Cleartouch Light Unit Assembly, Radiancy (Israel), Ltd. (2003) Summary page 2.

## Most influential descendants
- K090312: Tria Acne Treatment System, Model Ats-1 Otc (2010), 1 descendant of its own
- K160821: Tria Sapphire (2016), 0 descendants of its own

## Indications for use
The SpectraGenics ATS-1 is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K060567
Methodology: https://510kreport.com/methodology