# K053047: Fraxel SR Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Mar 20, 2006 after 143 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: 9 generations back to K910422 (1992). 113 ancestors in all.
205 later devices descend from it; 4 cite it directly.
0 of 319 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050841: Fraxel SR Laser System, Reliant Technologies, Inc. (2005) Summary page 2.
- K033461: Candela Vbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 2.
- K033331: Candela Cbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 2.
- K041242: Candela Smoothbeam Laser System, Candela Corp. (2004) Summary page 2.
- K043046: Cooltouch, Model CT3S, New Star Lasers, Inc. (2005) Summary page 2.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 2.

## Most influential descendants
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 descendants of its own
- K071051: Fraxel Iii SR Laser System and Accessories (2007), 194 descendants of its own
- K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories (2008), 187 descendants of its own
- K083900: Erbium Fractional Handpiece (2009), 158 descendants of its own
- K100270: Artisan Aesthetic System (2010), 157 descendants of its own

## Indications for use
The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of surgical scars and acne scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.

Source page: https://510kreport.com/device/K053047
Methodology: https://510kreport.com/methodology