# K063808: Fraxel IV SR Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Apr 27, 2007 after 126 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: 11 generations back to K910422 (1992). 128 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062303: Fraxel II SR Laser System, Reliant Technologies, Inc. (2007). Cleared while this submission was under review Summary page 1.
- K050841: Fraxel SR Laser System, Reliant Technologies, Inc. (2005) Summary page 1.

## Most influential descendants
- K130193: Fraxel Dual 1550/1927 Laser System (2013), 25 descendants of its own
- K171009: LASEMD Laser System (2017), 8 descendants of its own
- K110349: Clear+Brilliant Laser System (2011), 6 descendants of its own
- K182173: Joule System (2019), 5 descendants of its own
- K223727: Lavieen (2023), 4 descendants of its own

## Indications for use
The Fraxel IV 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/K063808
Methodology: https://510kreport.com/methodology