510(k) Report

FDA applicant

Solta Medical, Inc.

Bothell, WA13 decisions2009–20243 recalls

FDA records 13 decisions for Solta Medical, Inc. (Bothell, WA) from 2009 to 2024: 13 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 8 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Solta Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Solta Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2009: 22011: 12012: 22013: 22017: 12018: 12019: 22022: 12024: 1
2009high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2023

2010: 12019: 12023: 1
2009high 1 (2010) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Solta Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Solta Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • GEXPowered Laser Surgical Instrument3decisions
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output3decisions
  • QPBSystem, Suction, Lipoplasty For Removal2decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 92 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 201311cite it
  • K170758Thermage FLX System and AccessoriesSolta Medical · 20178cite it
  • K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 20094cite it
  • K110349Clear+Brilliant Laser SystemSolta Medical, Inc. · 20113cite it
  • K091420Fraxel RE: Store Laser System, Model SR1500Solta Medical, Inc. · 20093cite it
  • K132431Thermage CPT SystemSolta Medical, Inc. · 20132cite it

What has FDA decided for it lately?

  • K242142Fraxel® FTX Laser SystemSolta Medical · 2024
  • K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc. · 2022
  • K190551VASERlipo SystemSolta Medical · 2019
  • K190555PowerX Lipo SystemSolta Medical · 2019
  • K173759Thermage CPT System and AccessoriesSolta Medical · 20181 recall
  • K170758Thermage FLX System and AccessoriesSolta Medical · 2017
  • K132431Thermage CPT SystemSolta Medical, Inc. · 20131 recall
  • K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc. · 2013

All 8 as Solta Medical, Inc. →All 5 as Solta Medical →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K173759thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF…Feb 16, 2023Class II
  • K132431Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF…Dec 30, 2019Class II
  • K091420Fraxel re:store Dual Laser System----a laser surgical instrument for use in general and…Dec 15, 2010