FDA.reportPublic FDA data

"M22 IPL ""AC"" Filter"

Primary DI
07290117772218
Brand
"M22 IPL ""AC"" Filter"
Company
LUMENIS BE LTD
Model
NA
Published
2023-08-10
Public version status
New
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
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170060000M22 and ResurFx SystemsLumenis, Ltd.2017-08-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117772218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117772218072901177722187290117772218

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological laser beam guiding handpieceA hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site 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 is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600763501
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117772737Multi-Spot™ Nd:YAG HeadNA2025-12-21
07290117772744M22™ Q-Switched HeadNA2025-12-21
07290117772751Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kitNA2025-12-21
07290117772768Stellar M22™ Q-Switched Nd:YAG Upgrade KitNA2025-12-21
07290117772645Black Stellar XPL HPNA2025-09-08
07290117772652Stellar XPL Module KitNA2025-09-08
07290117772447FoLiCool™ TipNA2024-03-17
07290117772522FoLix™NA2024-03-17
07290117772539FoLix™ HandpieceNA2024-03-17
07290117772393LUSTER SystemNA2024-01-22
07290117772409LUSTER HandpieceNA2024-01-22
07290117772416LUSTER Tip, RoundNA2024-01-22
07290117771037LightSheer Duet, with ET and HS HandpiecesNA2023-06-22
07290117771068LightSheer Desire LightNA2023-06-22
07290117771082LightSheer Desire, BasicNA2023-06-22
07290117771044LightSheer® Duet ET™ HandpieceNA2023-03-22
07290117771051LightSheer® Duet HS™ HandpieceNA2023-03-22
17290117772420OPT™ ShieldsNA2023-12-26
17290117771829DeepFX Disposable TipsNA2023-12-04
17290117771836DeepFX Air Disposable TipsNA2023-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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
08800020109576FootswitchJeisys Medical Inc.ONG2026-07-16
08800020109613FootswitchJeisys Medical Inc.ONG2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.ONG2026-07-16