FDA.report

Braun Silk Expert Mini

Primary DI
00690558898930
Brand
Braun Silk Expert Mini
Company
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Model
PL1014
Device description
Light Based Over-The-Counter Hair Removal
Published
2021-08-26
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

Related Records

Product Codes

CodeName
OHTLight Based Over-The-Counter Hair Removal

Product Code Classifications

CodeDeviceSpecialtyClass
OHTLight Based Over-The-Counter Hair RemovalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10069055889890PackageGS12In Commercial Distribution
00690558898930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1006905588989010069055889890
00690558898930006905588989306905588989300690558898930

GMDN Terms

TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
004238200
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandCompanyProduct codePublished
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