Home GUDID 00841494100049 SculpSure Applicator
Primary DI 00841494100049
Brand SculpSure Applicator
Company Cynosure, LLC
Model 100-7026-100
Device description SculpSure Applicator
Published 2017-07-26
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 Code Name PKT Laser for disruption of adipocyte cells for aesthetic use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841494100049 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841494100049 00841494100049 841494100049 0841494100049
GMDN Terms# Term, Definition table Term Definition Low-intensity laser fat liquefaction system An assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function.
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 DI Brand Model Catalog Published 00841494100025 Focus Cap Array 100-7012-055 2016-09-24 00841494100001 PicoSure 100-7012-010 2016-09-24 00841494100056 Elite MPX 100-7009-010 2016-09-24 00841494100063 Elite+ 100-7018-010 2016-09-24 00841494100070 Apogee+ 100-7018-290 2016-09-24 00841494100100 Accolade 100-7008-010 2016-09-24 00841494100551 Spacer tip, handpiece 130-7012-324 2016-09-24 00841494100568 Spacer tip for 532 Handpiece 130-7012-490 2016-09-24 00841494103354 532 Lite Handpiece 659-0644 2016-09-24 00841494103583 PicoSure 1064 nm Handpiece 100-7012-079 2016-09-24 00841494103590 PicoSure 532 nm Handpiece 100-7012-076 2016-09-24 00841494103675 Elite+ / Elite MPX Treatment Tip 100-7018-100 2016-09-24 00841494106775 SculpSure, Laser Assembly, Brazil 100-7026-020 2017-07-24 00841494106980 PicoSure 532 Delivery System 100-7012-532 2017-07-24 00841494106997 PicoSure 1064 Delivery System 100-7012-164 2017-07-24 00841494107246 Refusrbished, Handpiece, 1064, Pico R100-7012-079 2017-07-24 00841494107253 Refusrbished, Handpiece, 532, Pico R100-7012-076 2017-07-24 00841494104214 PERF-GRID EPG107 EPG107 2016-09-21 00841494104689 SPLINT GRID NYLON MESH ROLL ESG118 ESG118 2016-09-21 00841494104696 SPLINT MESH STAINLESS STEEL MESH ROLL ESG117 ESG117 2016-09-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08057017760689 DEKA PHYSIQ 360 DEKA M.E.L.A. SRL PKT 2023-10-11 00810060830444 Venus Bliss Venus Concept Inc. PKT 2023-06-08 00810060830987 Venus Bliss Max Venus Concept Inc. PKT 2023-06-08 07290016541281 BLISS SYSTEM VENUS CONCEPT LTD PKT 2021-07-14 07290016541632 BLISS SYSTEM VENUS CONCEPT LTD PKT 2021-07-14 07290016541564 BODY LASER APPLICATOR SERVICE PACK, Bliss VENUS CONCEPT LTD PKT 2021-07-14 07290016541618 (MP)2 APPLICATOR BLISS VENUS CONCEPT LTD PKT 2021-07-14 07290016541625 BODY LASER APPLICATOR BLISS VENUS CONCEPT LTD PKT 2021-07-14 07290016541717 (MP)2 APPLICATOR SERVICE PACK, Bliss VENUS CONCEPT LTD PKT 2021-07-14 07290016541724 Belt Bliss VENUS CONCEPT LTD PKT 2021-07-14 06970745918516 Apolomed Shanghai Apolo Medical Technology Co.,Ltd PKT 2021-03-26 00841494107925 ASSY, MASK, Petite, Submental Adapter Cynosure, LLC PKT 2019-09-18 00841494107994 RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY Cynosure, LLC PKT 2018-01-18 00841494107956 ASSY, FINAL LASER, SCULPSURE, SUB ONLY Cynosure, LLC PKT 2017-11-29 00841494107963 ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL Cynosure, LLC PKT 2017-11-29 00841494107468 ASSY, MASK FLEX CIRCUIT, MED, SUB Cynosure, LLC PKT 2017-09-26 00841494100032 SculpSure laser assembly Cynosure, LLC PKT 2017-07-26 00841494106867 SculpSure Applicator, Refurbished Cynosure, LLC PKT 2017-07-24 00841494106775 SculpSure, Laser Assembly, Brazil Cynosure, LLC PKT 2017-07-24