# K062303: Fraxel II SR Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Jan 31, 2007 after 176 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). 127 ancestors in all.
226 later devices descend from it; 6 cite it directly.
0 of 354 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060310: Fraxel II SR Laser System and Accessories, Reliant Technologies, Inc. (2006) Summary page 1.
- 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.

## 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
- 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
- K090195: Palomar LUX1540 Handpiece (2009), 158 descendants of its own

## Indications for use
'The Fraxel II SR Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical 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/K062303
Methodology: https://510kreport.com/methodology