9 results
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54ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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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.
FDA Enforcement
Class II
·Ongoing·Solta Medical Inc·April 19, 2023
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).
FDA Enforcement
Class II
·Terminated·Solta Medical Inc·August 30, 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).
FDA Enforcement
Class II
·Terminated·Solta Medical Inc·August 30, 2017
FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.
FDA Enforcement
Class II
·Terminated·Solta Medical, Inc.·April 23, 2014
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.
FDA Enforcement
Class II
·Terminated·Solta Medical Inc·April 15, 2020
Medical Action INDUSTRIES INC., Disposable Instrument Pack Mosquito Hemostat, REF 56220
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., General Purpose Instrument Tray, REF 61209
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021
Medical Action INDUSTRIES INC., Disposable Instrument Pack Curved Hemostat, REF 56224
FDA Enforcement
Class II
·Terminated·Medical Action Industries, Inc. 306·June 30, 2021