Solta Medical Inc

FDA Filings

This page includes the latest FDA filings for Solta Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3011423170
FEI Number3004106598
NameSolta Medical, Inc.
Owner & OperatorSolta Medical, Inc. a div. of Bausch Health US LLC
Contact Address400 Somerset Corporate Blvd --
Bridgewater NJ 08807 US
Official Correspondent
  • Harry Jeffreys
  • x-908-5418650-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address11720 N Creek Pkwy N Suite 100
Bothell, WA 98011 US
Establishment Type
  • Repack or Relabel Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Remanufacture Medical Device
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
SOLTA MEDICAL, INC.
THERMAGE CPT SYSTEM2013-09-06
SOLTA MEDICAL, INC.
FRAXEL DUAL 1550/1927 LASER SYSTEM2013-06-14
SOLTA MEDICAL, INC.
ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM2012-06-05
SOLTA MEDICAL, INC.
CLEAR + BRILLIANT LASER SYSTEM2012-04-02
SOLTA MEDICAL, INC.
CLEAR+BRILLIANT LASER SYSTEM2011-05-03
SOLTA MEDICAL, INC.
FRAXEL RE: STORE LASER SYSTEM, MODEL SR15002009-10-14
SOLTA MEDICAL, INC.
THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES2009-06-26

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