FDA.reportPublic FDA data

Remington

Primary DI
00074590546033
Brand
Remington
Company
SPECTRUM BRANDS, INC.
Model
IPL2500USA
Device description
Intense Pulse Light OTC hair removal device
Published
2019-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K133201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133201000SHASER V-MINI 2 HAIR REMOVAL SYSTEMShaser, Inc.2014-02-12ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10074590546030PackageGS14In Commercial Distribution
00074590546033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007459054603010074590546030
00074590546033000745905460330745905460330074590546033

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.

Contacts#

Phone, Email table
PhoneEmail
800-736-4648xx@xx.xx

Regulatory Flags#

DUNS number
001951946
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00074590512175Remington ProductsIPL6000USA2016-09-30
00074590512182Remington ProductsSP6000SB2016-09-30
00074590530407Remington ProductsIPL6000Q2016-09-30
00074590533316Remington ProductsSP6000Q2016-09-30
00074590535471RemingtonIPL2000USA2019-09-26
00074590540345Luma RxIPL6800USA2016-09-30
00074590542370Luma RxSP6800SB2016-09-30
00074590542929RemingtonSP2000HR2019-09-25
00074590542974Remington ProductsIPL6000Q-R2016-09-30
00074590543131Luma RxIPL6800R2016-09-30
00074590543865Luma RxSP6800BC2016-09-30
00074590543872Luma RxSP6800FC2016-09-30
00074590544268Remington ProductsIPL6500QFB2016-09-30
00074590547894RemingtonSP7SB2019-09-26
00074590552560RemingtonIPL70002019-09-26
00074590544503RemingtonIPL75102019-09-26
10074590535478RemingtonIPL2000USA2019-09-26
10074590546030RemingtonIPL2500USA2019-09-26
10074590547891RemingtonSP7SB2019-09-26
10074590552567RemingtonIPL70002019-09-26

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Primary DI, Brand, Company table
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00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
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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