# K063038: Fraxel Iii SR Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Apr 27, 2007 after 207 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: 10 generations back to K910422 (1992). 144 ancestors in all.
195 later devices descend from it; 2 cite it directly.
0 of 340 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053047: Fraxel SR Laser System, Reliant Technologies, Inc. (2006) Summary page 1.
- K050841: Fraxel SR Laser System, Reliant Technologies, Inc. (2005) Summary page 1.
- K042319: Reliant Laser II System and Accessories, Reliant Technologies, Inc. (2005) Summary page 1.
- K040617: Reliant Laser System II, Reliant Technologies, Inc. (2004) Summary page 1.
- K031795: Reliant Laser System, Reliant Technologies, Inc. (2003) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces (2010), 156 descendants of its own

## Indications for use
The Fraxel III SR Laser System and accessories is intended for use in: Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.

Source page: https://510kreport.com/device/K063038
Methodology: https://510kreport.com/methodology