FDA.reportPublic FDA data

SmoothCool

Primary DI
08800020103017
Brand
SmoothCool
Company
Jeisys Medical Inc.
Model
SmoothCool
Device description
Phototherapy unit
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092326000SMOOTHCOOLJeisys Medical, Inc.2010-03-05ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
8800020103024PackageGS11In Commercial Distribution
08800020103017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
8800020103024088000201030248800020103024
08800020103017088000201030178800020103017

GMDN Terms#

Term, Definition table
TermDefinition
Intense pulsed light skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.

Regulatory Flags#

DUNS number
690275362
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020108333DENSITY TipClassic-B Tip2026-03-16
08800020108340DENSITY TipClassic-E Tip2026-03-16
08800020108357DENSITY TipClassic-F Tip2026-03-16
08800020108364DENSITY TipHigh-B Tip2026-03-16
08800020108371DENSITY TipHigh-E Tip2026-03-16
08800020108388DENSITY TipHigh-F Tip2026-03-16
08800020101525POTENZANeutral Electrode Pad Cable2026-03-16
08800020108166DENSITYFoot switch2026-03-16
08800020108173DENSITYPower cord2026-03-16
08800020108180DENSITYNeutral Electrode Pad cable2026-03-16
08800020108197DENSITYHandpiece holder2026-03-16
08800020108203DENSITYHandpiece cradle2026-03-16
08800020108289DENSITY TipClassic-B Tip2026-03-16
08800020108272DENSITY TipClassic-E Tip2026-03-16
08800020108296DENSITY TipClassic-F Tip2026-03-16
08800020108302DENSITY TipHigh-B Tip2026-03-16
08800020108319DENSITY TipHigh-E Tip2026-03-16
08800020108326DENSITY TipHigh-F Tip2026-03-16
08800020108395POTENZAFoot Switch2026-03-16
08800020108401POTENZAPower Cable2026-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019840428Silk'nSilkn Beauty Ltd.ONF2026-05-06
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDONF2026-04-08
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.ONF2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLONF2025-12-16
07290117772645Black Stellar XPL HPLUMENIS BE LTDONF2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDONF2025-09-08
07290016633313Plus ApplicatorINMODE M.D LTDONF2025-07-27
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.ONF2024-11-27
06976573489105BilensShanghai Bele Medical Technology Co., Ltd.ONF2024-11-24
07290016681093iProEliteFORMATK SYSTEMS LTDONF2024-10-15
06928258000891GSDShenzhen GSD Tech Co., Ltd.ONF2024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd.ONF2024-09-19
08034108512464PRISMADEKA M.E.L.A. SRLONF2024-09-17
07290019863144Lumecca PeakINMODE M.D LTDONF2024-08-15
07290019863151Lumecca PeakINMODE M.D LTDONF2024-08-15
00850033906004XLase PlusBIOTEC ITALIA SRLONF2024-07-29
0880970938041110PLTENTECH Inc.ONF2024-06-28
0880970938043510PLTENTECH Inc.ONF2024-06-28
00850062978003WORLD AESTHETIX BROAD PULSED LIGHTWORLD AESTHETIX LLCONF2024-06-25