Home GUDID 00841494100360 ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
Primary DI 00841494100360
Brand ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
Company Cynosure, LLC
Model 100-7051-068
Device description ASSY, FOCUS ARRAY, 3PK, W/BOX, PICO300
Published 2021-08-05
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 GEX Powered laser surgical instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEX Powered Laser Surgical Instrument General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841494100360 Primary GS1 0 00841494100230 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841494100360 00841494100360 841494100360 0841494100360 00841494100230 00841494100230 841494100230 0841494100230
GMDN Terms# Term, Definition table Term Definition Multi-modality skin surface treatment system An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.
Regulatory Flags# DUNS number 780318028 Device count 3 Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841494100032 SculpSure laser assembly 100-7026-010 2017-07-26 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
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