FDA.reportPublic FDA data

Fraxel re:store DUAL Laser System

Primary DI
00816995027010
Brand
Fraxel re:store DUAL Laser System
Company
SOLTA MEDICAL
Model
MC-SYS-SR1500-D-USR
Catalog number
MC-SYS-SR1500-D-USR
Device description
Re:Store DUAL Domestic, Refurbished
Published
2017-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816995027010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816995027010008169950270108169950270100816995027010

GMDN Terms#

Term, Definition table
TermDefinition
Laser skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated laser-based energies (e.g., Er:YAG lasers; Er:Glass lasers, long-pulsed Nd:YAG laser, and Q-switched Nd:YAG laser) used for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This device is connected to a generator and is applied by a practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079999584
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816995027850Fraxel FTXMC-BURNPAPER-LMC-BURNPAPER-L2026-07-20
00816995027867Fraxel FTXMC7MM24MC7MM242026-07-20
00816995027874Fraxel FTXMC15MM24MC15MM242026-07-20
00816995027904Fraxel FTXMCSYSFTX-LOANERMCSYSFTX-LOANER2026-07-20
00816995027461CLEAR+BRILLIANT TOUCHCBT-CONSOLE-RCBT-CONSOLE-R2020-09-01
00816995027478CLEAR+BRILLIANT TOUCHCBT-HP-1440-RCBT-HP-1440-R2020-09-01
00816995027485CLEAR+BRILLIANT TOUCHCBT-HP-1927-RCBT-HP-1927-R2020-09-01
00816995027317CLEAR+BRILLIANT TOUCHCBT-HP-1440CBT-HP-14402020-07-13
00816995027324CLEAR+BRILLIANT TOUCHCBT-HP-1927CBT-HP-19272020-07-13
00816995027331CLEAR+BRILLIANT TOUCHCBT-KEY-12CBT-KEY-122020-07-13
00850608002476PowerX Lipo System110-0020110-00202016-09-23
00850608002544PowerX Lipo System110-0039110-00392016-09-23
00816995020233Fraxel re:store DUAL Laser SystemMC-SYS-SR1500-D-USMC-SYS-SR1500-D-US2016-09-23
00816995026921PowerX Lipo System110-0020R110-0020R2017-12-14
00816995026990PowerX Lipo System110-0039R110-0039R2017-12-14
00816995027300CLEAR+BRILLIANT TOUCHCBT-CONSOLECBT-CONSOLE2020-07-13
00816995027799Fraxel FTXMCSYSFTX-RMCSYSFTX-R2025-04-02
00816995027805Fraxel FTXMCSYSFTXMCSYSFTX2025-04-02
00816995027249THERMAGETF-3-60TF-3-602019-11-08
00816995027256THERMAGETF-3-30TF-3-302019-11-08

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Primary DI, Brand, Company table
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08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16