Home GUDID 00841494100032 SculpSure laser assembly
Primary DI 00841494100032
Brand SculpSure laser assembly
Company Cynosure, LLC
Model 100-7026-010
Device description SculpSure laser assembly
Published 2017-07-26
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00841494100032 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 00841494100032 00841494100032 841494100032 0841494100032
GMDN Terms# Term, Definition table Term Definition Low-intensity laser fat liquefaction system, mobile 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841494100049 SculpSure Applicator 100-7026-100 2017-07-26 00841494106867 SculpSure Applicator, Refurbished R100-7026-100 2017-07-24 00841494107468 ASSY, MASK FLEX CIRCUIT, MED, SUB 100-7026-816 2017-09-26 00841494107956 ASSY, FINAL LASER, SCULPSURE, SUB ONLY 100-7026-910 2017-11-29 00841494107963 ASSY, FNL LASER, SCULPSURE, SUB ONLY BRAZIL 100-7026-920 2017-11-29 00841494107994 RFB, ASSY, FINAL LASER, SCULPSURE, SUB ONLY R100-7026-910 2018-01-18 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
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 00841494100049 SculpSure Applicator 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