Solta Medical, Inc.
Solta Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2022, with 5 FDA device recalls on record.
Top product codes for Solta Medical, Inc.
FDA recalls by Solta Medical, Inc.
- Z-1354-2023 — thermage THERMAGE CPT SYSTEM REF TG-2B *** Solta Medical, Inc. thermage RF GENERATOR REF TG-2B *** Solta Medical, Inc. Dermatologic and general surgical procedures for electrocoagulation and hemostasis; " Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; " Non-invasive treatment of wrinkles and rhytids. The Thermage CPT System ( System ) consists of the RF Generator/ Cooling System, 16.00 cm2 Handpiece ( Body Handpiece ), Standard Handpiece with Vibration ( Face Handpiece ), optional electric Footswitch, accessory cables, Return Pad, Return Pad Cable, and Treatment Tips.
- Z-1681-2020 — Thermage Face Tip 3.0, REF/UDI: TTNS3,00C3-400/UDI (01)000850608002377; REF TTNS3.00C3-600/UDI (01)000850608002384; REF TTNS3.00C3-900; UDI (01)000850608002391 Used in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
- Z-3047-2017 — VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
- Z-3048-2017 — VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).
- Z-1463-2014 — FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Solta Medical, Inc.
- K223647 — CLEAR+BRILLIANT TOUCH® Laser System
- K132431 — THERMAGE CPT SYSTEM
- K130193 — FRAXEL DUAL 1550/1927 LASER SYSTEM
- K121515 — ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM
- K120433 — CLEAR + BRILLIANT LASER SYSTEM
- K110349 — CLEAR+BRILLIANT LASER SYSTEM
- K091420 — FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500
- K090580 — THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.