# Solta Medical, Inc.

- Location (FDA's records): Bothell, WA
- FDA decisions: 13 (2009–2024): 13 510(k) clearances
- Names in FDA's records: Solta Medical, Inc. (8); Solta Medical (5)
- Product codes: GEI (4), GEX (3), ONG (3), QPB (2), ONF (1)
- 510(k) review time since 2016: median 29 days, against 92 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 31 (8 its own); citations of its devices by later devices: 35 (8 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Thermage, Inc.: 9 (https://510kreport.com/company/thermage)
- Alma Lasers, Inc.: 3 (https://510kreport.com/company/alma-lasers)
- Syneron Medical, Ltd.: 3 (https://510kreport.com/company/syneron-medical)
- Reliant Technologies, Inc.: 2 (https://510kreport.com/company/reliant-technologies)
- Sound Surgical Technologies, LLC: 2 (https://510kreport.com/company/sound-surgical-technologies)
- Ellman Int'L, Inc.: 1 (https://510kreport.com/company/ellman-int-l)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Lpg USA, Inc.: 1 (https://510kreport.com/company/lpg-usa)

## Firms that cite its devices most
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Ellipse A/S: 2 (https://510kreport.com/company/ellipse-a-s)
- Lutronic Corporation: 2 (https://510kreport.com/company/lutronic)
- We Medical Technology (Wuxi) Co., Ltd.: 1 (https://510kreport.com/company/we-medical-technology-wuxi)
- Shanghai Apolo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Eunsung Global Corp: 1 (https://510kreport.com/company/eunsung-global)
- AVAVA, Inc.: 1 (https://510kreport.com/company/avava)
- Jeisys Medical, Inc.: 1 (https://510kreport.com/company/jeisys-medical)

## Its most-cited devices
- K130193: Fraxel Dual 1550/1927 Laser System (2013), cited by 11
- K170758: Thermage FLX System and Accessories (2017), cited by 8
- K090580: Thermage Thermacool NXT System and Accessories (2009), cited by 4
- K110349: Clear+Brilliant Laser System (2011), cited by 3
- K091420: Fraxel RE: Store Laser System, Model SR1500 (2009), cited by 3
- K132431: Thermage CPT System (2013), cited by 2

## Recent decisions
- K242142: Fraxel® FTX Laser System (Aug 21, 2024)
- K223647: CLEAR+BRILLIANT TOUCH® Laser System (Dec 29, 2022)
- K190551: VASERlipo System (May 1, 2019)
- K190555: PowerX Lipo System (May 1, 2019)
- K173759: Thermage CPT System and Accessories (Jan 8, 2018)
- K170758: Thermage FLX System and Accessories (Sep 22, 2017)
- K132431: Thermage CPT System (Sep 6, 2013)
- K130193: Fraxel Dual 1550/1927 Laser System (Jun 14, 2013)

Source page: https://510kreport.com/company/solta-medical