FDA.reportPublic FDA data

Multi-modality skin contouring system

Definition
An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.
GUDID devices
134
Last updated
2025-04-21 12:40:58

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08053782383283T-SHAPE 2B&M SRL MARKETING NEL BENESSERET-SHAPE 22025-04-11
07290016586671GENEO, GLO2FACIAL, ELITEPOLLOGEN LTDRF PRO handpiece kit for GENEO X system (USA Confi2025-02-11
07290016814668PURE DentAENDYMED MEDICAL LTDPURE DentA 110V2024-11-06
07290016814422EndyMed PRO MAX, Small MAX HandpieceENDYMED MEDICAL LTDSmall MAX Handpiece2024-05-16
07290016814439EndyMed PRO MAX, FSR MAX HandpieceENDYMED MEDICAL LTD FSR MAX Handpiece2024-05-16
07290016814446EndyMed PRO MAX, iFine MAX HandpieceENDYMED MEDICAL LTD iFine MAX Handpiece 2024-05-16
07290016814453EndyMed PRO MAX,Shaper MAX HandpieceENDYMED MEDICAL LTDShaper MAX Handpiece2024-05-16
07290016814460EndyMed PRO MAX,Mini Shaper MAX HandpieceENDYMED MEDICAL LTDMini Shaper MAX Handpiece 2024-05-16
07290016814477EndyMed PRO MAX, Contour MAX HandpieceENDYMED MEDICAL LTDContour MAX Handpiece2024-05-16
07640260120037FAQ 101Foreo ABAmethyst2024-03-01
07290016586459Desire model UPOLLOGEN LTDDesire model U2023-12-15
07290016586626STOP VX2 MODEL U POLLOGEN LTDSTOP VX2 MODEL U 2023-12-14
00817495022727Vcontour applicatorCandela CorporationFG710122023-10-20
00817495022789Vsmooth applicatorCandela CorporationFG711712023-10-20
00817495023861SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape IIICandela CorporationKT750612023-10-20
00817495023878LA Replaceable Cover (4 Hr) 5-PkCandela CorporationKT751022023-10-20
00817495024066Replaceable Cover, Vsmooth 4HrCandela CorporationAS859932023-10-20
00817495024271SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III Candela CorporationFG70412JP2023-10-20
00817495024455SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape IIICandela CorporationAS875122023-10-20
00817495024462SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIICandela CorporationAS833332023-10-20
00817495024516SA Small Repl. Cover 10x13mm, 4Hr, Velashape III Candela CorporationAS833222023-10-20
00817495024561SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape IIICandela CorporationKT750722023-10-20
00817495024578SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIICandela CorporationKT756722023-10-20
07290016586466STOP VX GOLD MODEL UPOLLOGEN LTDSTOP U MODEL UXV2021-11-07
08057017760443Thermaeye PlusEL.EN. SPAM081AN12021-10-19
07290016586442STOP VX MODEL UPOLLOGEN LTDSTOP U MODEL UXV2021-06-30
07290018007686STOP XPOLLOGEN LTDSTOP U2020-12-22
07290109952703SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III SYNERON MEDICAL LTDAS875122017-06-01
07290018007303STOP XPOLLOGEN LTDModel U2019-11-07
00872320004460Ultimate Contour MiniCAO GROUP, INC.005-000362019-09-06
17290109950416SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, VelashapeSYNERON MEDICAL LTDKT750612016-09-26
17290109950423SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, VelasSYNERON MEDICAL LTDKT756712016-09-26
17290109950430SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape SYNERON MEDICAL LTDKT750712016-09-26
17290109952151LA Repl. Stacking Covers (8 Hr) 5-Pk SYNERON MEDICAL LTDKT748312016-09-26
17290109952212LA Replaceable Cover (4 Hr) 5-PkSYNERON MEDICAL LTDKT751022016-09-26
37290109950342LA Repl. Cvr. (1Hr) 10-PkSYNERON MEDICAL LTDKT717452016-09-26
37290109950359SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II SYNERON MEDICAL LTDKT717512016-09-26
37290109950410SA Repl. Small Cvr. 10x13mm (4 Hr) 10-Pk, VelashapSYNERON MEDICAL LTDKT7425A2016-09-26
37290109950427SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 10-Pk, VelaSYNERON MEDICAL LTDKT756612016-09-26
37290109950434SA Repl. Med. Cvr. 25x30mm (4 Hr) 10-Pk, VelashapeSYNERON MEDICAL LTDKT7426A2016-09-26
37290109952162LA Repl. Stacking Covers (16 Hr) 10-PkSYNERON MEDICAL LTDKT748412016-09-26
17290014660004NEWA KitENDYMED MEDICAL LTD1.5, Ivory2018-09-30
17290014660455NEWA KitENDYMED MEDICAL LTD1.5, Ivory demo2018-09-30
17290014660837NEWA KitENDYMED MEDICAL LTD1.5, pink2018-09-30
17290014660967NEWA KitENDYMED MEDICAL LTD1.5, red2018-09-30
07290016746259V-FORMVIORA LTDVTL459002016-09-23
07290016746266BC Large Applicator VIORA LTDVTL459202016-09-23
07290016746273BC Small Applicator VIORA LTDVTL459102016-09-23
07290016746303Reaction™ VIORA LTDVRE01102016-09-23
07290016746310ST ApplicatorVIORA LTDVRE20012016-09-23
07290016746327BC Applicator VIORA LTDVRE20022016-09-23
07290016746334FC ApplicatorVIORA LTDVRE20032016-09-23
07290016746419BC Medium ApplicatorVIORA LTDVTL459302017-07-05
07290016814019EndyMed Pure Small HandpieceENDYMED MEDICAL LTDSmall Handpiece2018-12-31
07290016814026EndyMed Pure FSR HandpieceENDYMED MEDICAL LTDFSR Handpiece2018-12-31
07290016814033EndyMed Pure iFine HandpieceENDYMED MEDICAL LTDiFine Handpiece2018-12-31
07290016814040EndyMed Pure Shaper HandpieceENDYMED MEDICAL LTDShaper Handpiece2018-12-31
07290016814057EndyMed Pure mini-shaper HandpieceENDYMED MEDICAL LTDmini-shaper Handpiece2018-12-31
07290016814071EndyMed PRO mini-shaper HandpieceENDYMED MEDICAL LTDmini-shaper Handpiece2018-12-31
07290016814088EndyMed PRO Contour HandpieceENDYMED MEDICAL LTDCountour Handpiece2018-12-31
07290016814101EndyMed Pro Small HandpieceENDYMED MEDICAL LTDPro Small Handpiece2018-12-31
07290016814125EndyMed Pro FSR HandpieceENDYMED MEDICAL LTDPro FSR Handpiece2018-12-31
07290016814132EndyMed Pro iFine HandpieceENDYMED MEDICAL LTDPro iFine Handpiece2018-12-31
07290016814149EndyMed Pro Shaper HandpieceENDYMED MEDICAL LTDPro Shaper Handpiece2018-12-31
07290016814156EndyMed PRO 85W System 110VENDYMED MEDICAL LTDPRO 85W System 110V2019-03-03
07290016814163EndyMed PRO 85W System Body 110VENDYMED MEDICAL LTDPRO 85W System Body 110V2019-03-03
07290016814170EndyMed PRO 85W System Face 110VENDYMED MEDICAL LTDPRO 85W System Face 110V2019-03-03
07290016814187EndyMed PRO 85W System 220V ENDYMED MEDICAL LTDPRO 85W System 220V 2019-03-03
07290016814194EndyMed PRO 85W System Body 2200VENDYMED MEDICAL LTDPRO 85W System Body 2200V2019-03-03
07290016814200EndyMed PRO Intensif HandpieceENDYMED MEDICAL LTDIntesif Handpiece2018-12-31
07290016814217EndyMed Pure Intensif Handpiece ENDYMED MEDICAL LTDIntensif Handpiece2018-12-31
07290016814224EndyMed PRO 85W System Face 220VENDYMED MEDICAL LTDPRO 85W System Face 220V2019-03-03
07290016814231EndyMed Pure 2.0 system 220V PURE logoENDYMED MEDICAL LTDPure 2.0 system 220V PURE logo2019-03-03
07290016814279EndyMed Pure 2.0 system 110V PURE logoENDYMED MEDICAL LTDPure 2.0 system 110V PURE logo2019-03-03
07290016814286EndyMed Pure system 220VENDYMED MEDICAL LTDPure system 220V2019-03-03
07290016814293EndyMed Pure 85W system 220VENDYMED MEDICAL LTDPure 85W system 220V2019-03-03
07290016814323EndyMed Intensif 10 Tips PackageENDYMED MEDICAL LTDIntensif 10 Tips Package2019-01-31
07290016814330EndyMed Intensif 10 pack tips packageENDYMED MEDICAL LTDIntensif 10 pack tips package2019-01-31
07290016814347EndyMed FSR 10 Tips Package - sterileENDYMED MEDICAL LTDFSR 10 Tips Package - sterile2019-01-31
07290109950242VelaShape systemSYNERON MEDICAL LTDFG001312016-09-20