# K080915: Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Jul 1, 2008 after 90 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: 12 generations back to K910422 (1992). 149 ancestors in all.
187 later devices descend from it; 3 cite it directly.
0 of 337 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063038: Fraxel Iii SR Laser System and Accessories, Reliant Technologies, Inc. (2007) Summary page 1.
- K071051: Fraxel Iii SR Laser System and Accessories, Reliant Technologies, Inc. (2007) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.

## Most influential descendants
- 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
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own

## Indications for use
The Fraxel re:pair (Fraxel III SR) Laser System, including its resurfacing handpiece delivery system, is intended for use in: -Dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. -Treatment of wrinkles, rhytides, furrows, fine lines; -Pigmented lesions; -Textural irregularities; -Vascular dyschromia. The Fraxel re:pair (Fraxel III SR) Laser System, including its incisional and debulking delivery systems, are intended for ablation (removal), for the reduction, treatment and/or removal of: - Actinic and seborrheic keratoses; -Chelitis; -Cutaneous horns; -Hemangiomas; -Keloids; -Nevi, including spider, epidermal and protruding; -Rhinophyma; -Syringomas; -Warts; -Laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy of the lip.

Source page: https://510kreport.com/device/K080915
Methodology: https://510kreport.com/methodology