FDA.report

Remington Products

Primary DI
10074590533313
Brand
Remington Products
Company
SPECTRUM BRANDS, INC.
Model
SP6000Q
Device description
Consumable component for IPL6000 products
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications

CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K120080000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K120080000SHASER HRS2 HAIR REMOVAL SYSTEMShaser, Inc.2012-05-25ONF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10074590533313PackageGS124In Commercial Distribution
00074590533316PrimaryGS10

GMDN Terms

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

Contacts

PhoneEmail
1-800-736-4648xx@xx.xxx

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 DIBrandModelCatalogPublished
10074590535478RemingtonIPL2000USA2019-09-26
00074590544503RemingtonIPL75102019-09-26
10074590546030RemingtonIPL2500USA2019-09-26
10074590547891RemingtonSP7SB2019-09-26
10074590552567RemingtonIPL70002019-09-26
10074590542926RemingtonSP2000HR2019-09-25
10074590512172Remington ProductsIPL6000USA2016-09-30
10074590512189Remington ProductsSP6000SB2016-09-30
10074590530404Remington ProductsIPL6000Q2016-09-30
10074590540342Luma RxIPL6800USA2016-09-30
10074590542377Luma RxSP6800SB2016-09-30
10074590542971Remington ProductsIPL6000Q-R2016-09-30
10074590543138Luma RxIPL6800R2016-09-30
10074590543862Luma RxSP6800BC2016-09-30
10074590543879Luma RxSP6800FC2016-09-30
10074590544265Remington ProductsIPL6500QFB2016-09-30

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