FDA.reportPublic FDA data

Multi-modality skin surface treatment system generator

Definition
A mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used 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). Dedicated applicators are used to apply the different energies to the skin.
GUDID devices
36
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06978716980029Nd: YAG Laser Therapy SystemsSanhe Meditech Co.LtdGL0222026-05-13
07290016540383Venus VersaVENUS CONCEPT LTDVE1024072016-09-24
08800209800041PICO SHINING(PICOFY)SPECLIPSE, Inc.012026-05-21
08800209800058PICO SHINING(PICO-K)SPECLIPSE, Inc.012026-05-21
08800209800003PICO-KSPECLIPSE, Inc.012026-01-09
08800209800034PICOFYSPECLIPSE, Inc.012026-01-09
08800209800010BELLUS-QSPECLIPSE, Inc.012026-01-06
08800209800027QMODESPECLIPSE, Inc.012026-01-06
00817495025070Refurbished Applicator 1550 Candela CorporationFIN1012082025-05-20
00817495025087Refurbished Applicator 1940Candela CorporationFIN1012072025-05-20
00817495023960Nordlys MiniCandela Corporation 9SYS7853 2025-03-10
008174950235261940 ApplicatorCandela Corporation9APP7909 2025-03-06
008174950239531550 Applicator Candela Corporation9APP78302025-03-06
04058784002617DermablateAsclepion Laser Technologies GmbHM18-4200-0002024-11-11
04058784002624DermablateAsclepion Laser Technologies GmbHM18-4300-0002024-11-11
08800017500102ACTIVODaeju Medi Tech Engineering1.02024-09-30
06977620360026ZHEONEHebei Zhemai Technology Co., Ltd.FQ-L082024-09-19
08033945934767QuantabellaQUANTA SYSTEM SPAEAM0012742016-08-18
00841494103774ICON CONTROL MODULE REMANCynosure, LLC2520-0003R2022-08-05
00863172000311AerolaseAEROLASE CORPORATIONErbiumXL2021-12-23
00841494100520ASSY, 1540 HANDPIECE, ICONCynosure, LLC2520D-15402021-07-16
008414941022721540 HANDPIECE ICON, REMANUFACTUREDCynosure, LLC2520D-1540R2021-07-16
06973512860612HuameiShandong Huamei Technology Co.,Ltd.HM-YL9002021-04-23
06973537443005SUPERLASERBeijing Superlaser Technology Co., Ltd.SL-NY6022020-08-08
08033945934651Quanta forteQUANTA SYSTEM SPAPZMS000112016-08-18
08033945934668Quanta forteQUANTA SYSTEM SPAPZMS000122016-08-18
08033945934750Quanta forteQUANTA SYSTEM SPAPZMS000132016-08-18
B30520TC1290TheraClearTHERAVANT CORPORATION20TC12900AA2016-09-20
B30530TC0300TheraClearTHERAVANT CORPORATION30TC03000AA2016-09-19
B30530TC0730TheraClearTHERAVANT CORPORATION30TC073AA002016-09-19
B305THERACLEAR10TheraClearTHERAVANT CORPORATION40-TC116-00.AA2017-02-14
04058784000088MCL 31 DermablateAsclepion Laser Technologies GmbH18212016-11-14
04058784000224MCL 31 DermablateAsclepion Laser Technologies GmbH18232018-01-30
07290016540499Venus VersaVENUS CONCEPT LTDVE1024072016-09-24
07290016746006V30 Console VIORA LTDVTL400002016-09-23
00860564000317Spectrum Laser/IPLROHRER AESTHETICS, LLCSpectrum2016-09-22