FDA.reportPublic FDA data

SculpSure, Laser Assembly, Brazil

Primary DI
00841494106775
Brand
SculpSure, Laser Assembly, Brazil
Company
Cynosure, LLC
Model
100-7026-020
Device description
SculpSure, Laser Assembly, Brazil
Published
2017-07-24
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
PKTLaser for disruption of adipocyte cells for aesthetic use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic UseGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841494106775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841494106775008414941067758414941067750841494106775

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.

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
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
00841494106980PicoSure 532 Delivery System100-7012-5322017-07-24
00841494106997PicoSure 1064 Delivery System100-7012-1642017-07-24
00841494107246Refusrbished, Handpiece, 1064, PicoR100-7012-0792017-07-24
00841494107253Refusrbished, Handpiece, 532, PicoR100-7012-0762017-07-24
00841494104214PERF-GRIDEPG107EPG1072016-09-21
00841494104689SPLINT GRID NYLON MESH ROLLESG118ESG1182016-09-21
00841494104696SPLINT MESH STAINLESS STEEL MESH ROLLESG117ESG1172016-09-21
00841494100179Emerge0500-00012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057017760689DEKA PHYSIQ 360DEKA M.E.L.A. SRLPKT2023-10-11
00810060830444Venus BlissVenus Concept Inc.PKT2023-06-08
00810060830987Venus Bliss MaxVenus Concept Inc.PKT2023-06-08
07290016541281BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541632BLISS SYSTEMVENUS CONCEPT LTDPKT2021-07-14
07290016541564BODY LASER APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541618(MP)2 APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541625BODY LASER APPLICATOR BLISSVENUS CONCEPT LTDPKT2021-07-14
07290016541717(MP)2 APPLICATOR SERVICE PACK, BlissVENUS CONCEPT LTDPKT2021-07-14
07290016541724Belt BlissVENUS CONCEPT LTDPKT2021-07-14
06970745918516ApolomedShanghai Apolo Medical Technology Co.,LtdPKT2021-03-26
00841494107925ASSY, MASK, Petite, Submental AdapterCynosure, LLCPKT2019-09-18
00841494107994RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2018-01-18
00841494107956ASSY, FINAL LASER, SCULPSURE, SUB ONLYCynosure, LLCPKT2017-11-29
00841494107963ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZILCynosure, LLCPKT2017-11-29
00841494107468ASSY, MASK FLEX CIRCUIT, MED, SUBCynosure, LLCPKT2017-09-26
00841494100032SculpSure laser assemblyCynosure, LLCPKT2017-07-26
00841494100049SculpSure ApplicatorCynosure, LLCPKT2017-07-26
00841494106867SculpSure Applicator, RefurbishedCynosure, LLCPKT2017-07-24