# K091420: Fraxel RE: Store Laser System, Model SR1500

- Pathway: 510(k) (Traditional)
- Applicant: Solta Medical, Inc.
- Decided: Oct 14, 2009 after 154 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
62 later devices descend from it; 3 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K130028: Resurfx 1565NM Laser Module (2013), 41 descendants of its own
- K142860: Lumenis M22 System (2015), 38 descendants of its own
- K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US (2010), 28 descendants of its own
- K130193: Fraxel Dual 1550/1927 Laser System (2013), 25 descendants of its own
- K170060: M22 and ResurFx Systems (2017), 24 descendants of its own

## Recalls of this device
- 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 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. 1925 nm: The Fraxel re:store 1925 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue.

Source page: https://510kreport.com/device/K091420
Methodology: https://510kreport.com/methodology