# K050841: Fraxel SR Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Jul 5, 2005 after 95 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: 8 generations back to K910422 (1992). 65 ancestors in all.
238 later devices descend from it; 8 cite it directly.
0 of 304 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.

## Cited in the summary but kept off the family tree
- K043219: Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems, Interacoustics AS (2005). Our reading of the summary gave K043219, FDA’s number for Affinity (Cabinet Name), AC440, HIT440, or the Combination… (Interacoustics AS). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fraxel SR Laser System”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K060310: Fraxel II SR Laser System and Accessories (2006), 230 descendants of its own
- K062303: Fraxel II SR Laser System (2007), 226 descendants of its own
- K053047: Fraxel SR Laser System (2006), 205 descendants of its own
- 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

## Indications for use
The Reliant Laser System II is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; 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/K050841
Methodology: https://510kreport.com/methodology