FDA.reportPublic FDA data

MaxY Handpiece, Remanufactured

Primary DI
00841494107611
Brand
MaxY Handpiece, Remanufactured
Company
Cynosure, LLC
Model
2520B-Y026R
Device description
MaxY Handpiece, Remanufactured
Published
2017-09-28
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
ONGPowered laser surgical instrument with microbeamfractional output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110907000PALOMAR ICON (TM) AESTHETIC SYSTEMPalomar Medical Technologies, Inc.2011-06-22GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494107611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494107611008414941076118414941076110841494107611

GMDN Terms#

Term, Definition table
TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
780318028
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841494100032SculpSure laser assembly100-7026-0102017-07-26
00841494100049SculpSure Applicator100-7026-1002017-07-26
00841494106867SculpSure Applicator, RefurbishedR100-7026-1002017-07-24
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUB100-7026-8162017-09-26
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLY100-7026-9102017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL100-7026-9202017-11-29
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYR100-7026-9102018-01-18
00841494100025Focus Cap Array100-7012-0552016-09-24
00841494100001PicoSure100-7012-0102016-09-24
00841494100056Elite MPX100-7009-0102016-09-24
00841494100063Elite+100-7018-0102016-09-24
00841494100070Apogee+100-7018-2902016-09-24
00841494100100Accolade100-7008-0102016-09-24
00841494100551Spacer tip, handpiece130-7012-3242016-09-24
00841494100568Spacer tip for 532 Handpiece130-7012-4902016-09-24
00841494103354532 Lite Handpiece659-06442016-09-24
00841494103583PicoSure 1064 nm Handpiece100-7012-0792016-09-24
00841494103590PicoSure 532 nm Handpiece100-7012-0762016-09-24
00841494103675Elite+ / Elite MPX Treatment Tip100-7018-1002016-09-24
00841494106775SculpSure, Laser Assembly, Brazil100-7026-0202017-07-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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