FDA.reportPublic FDA data

CurrentBody Skin™

Primary DI
00655729008235
Brand
CurrentBody Skin™
Company
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Model
MK66R-B
Device description
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
Published
2024-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00655729008235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00655729008235006557290082356557290082350655729008235

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543062382
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850049532440HIGHERDOSEHG-120K2025-06-28
00731093153136CurrentBody Skin™MZ-072024-01-30
00695866567110CurrentBody Skin™EY-36B2025-06-28
00810137610429SOLAWAVEEY-20N2025-06-28
00810137610436SOLAWAVE610432025-06-28
00850049532471HIGHERDOSEMK66-L2025-06-28
00850062024557EXOCEUTICALSSZ-22A2025-06-28
00856957008022Dr NaomiMK-042025-06-28
05060282690301LustrePR60012025-06-28
05060282690318LustrePR50012025-06-28
06970006970918NOOANCEM-2822025-06-28
06970006970925NOOANCEM-1202025-06-28
06970006971144CosmotologyEY-20R2025-06-28
06970006971212EnergyLoungerTY-012025-06-28
00843041136433Tommie copper5008LD2022-01-26
00843041136907Tommie Copper5010LD2022-01-26
00850049532297HIGHERDOSEZLD-75W2024-01-23
00731093153914CurrentBody™MK-90C2025-03-06
05060282690325LUSTRE PR70012025-03-06
06970006971649 Lumaflex ZLD-05A2024-09-02

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