# K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Sep 8, 2010 after 99 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K910422 (1992). 128 ancestors in all.
28 later devices descend from it; 2 cite it directly.
0 of 157 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)
- K091420: Fraxel RE: Store Laser System, Model SR1500, Solta Medical, Inc. (2009) 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
- K182173: Joule System (2019), 5 descendants of its own
- K223727: Lavieen (2023), 4 descendants of its own
- K202884: SR-1 Skin Treatment System (2021), 4 descendants of its own

## Recalls of this device
- Mar 20, 2014 · Class II · Z-1463-2014: Obsolete versions of the Laser Treatment Settings card for the Fraxel DUAL 1550/1927 Laser system may have contained incorrect indication for use for treatment of Melasma.
- Dec 15, 2010 · Not classified · Z-1010-2011: The product has the potential to cause inadvertent laser firing which may lead to patient/operator injury if the problem recurs.

## Indications for use
1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. 1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.

Source page: https://510kreport.com/device/K101490
Methodology: https://510kreport.com/methodology