# K060310: Fraxel II SR Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Mar 29, 2006 after 50 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). 126 ancestors in all.
230 later devices descend from it; 6 cite it directly.
0 of 357 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 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K040617: Reliant Laser System II, Reliant Technologies, Inc. (2004) Summary page 2.
- K031795: Reliant Laser System, Reliant Technologies, Inc. (2003) Summary page 2.

## Most influential descendants
- K062303: Fraxel II SR Laser System (2007), 226 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
- K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System) (2007), 172 descendants of its own
- K080244: Palomar Lux 1540 Handpiece (2008), 161 descendants of its own

## Indications for use
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/K060310
Methodology: https://510kreport.com/methodology