FDA.reportPublic FDA data

Remington

Primary DI
10074590542926
Brand
Remington
Company
SPECTRUM BRANDS, INC.
Model
SP2000HR
Device description
Intense Pulse Light OTC hair removal device spare part
Published
2019-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
10074590542926PackageGS14In Commercial Distribution
00074590542929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007459054292610074590542926
00074590542929000745905429290745905429290074590542929

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 560 - 1200nm [intense pulsed light (IPL)] to cause heat ablation of pigmented skin cells (selective photothermolysis) to treat a variety of 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
001951946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00074590546033RemingtonIPL2500USA2019-09-26
00074590547894RemingtonSP7SB2019-09-26
00074590552560RemingtonIPL70002019-09-26
00074590544503RemingtonIPL75102019-09-26
10074590535478RemingtonIPL2000USA2019-09-26
10074590546030RemingtonIPL2500USA2019-09-26
10074590547891RemingtonSP7SB2019-09-26

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