# K130193: Fraxel Dual 1550/1927 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Solta Medical, Inc.
- Decided: Jun 14, 2013 after 140 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). 131 ancestors in all.
25 later devices descend from it; 11 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)
- K101490: Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-US, Thermage, Inc. (2010) Summary page 1.
- K063808: Fraxel IV SR Laser System, Reliant Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K161162: Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra (2016), 4 descendants of its own

## Indications for use
1550 nm: The Fraxel 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

Source page: https://510kreport.com/device/K130193
Methodology: https://510kreport.com/methodology