FDA.reportPublic FDA data

Solawave

Primary DI
00850035134368
Brand
Solawave
Company
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Model
HD-15
Device description
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Published
2024-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFOStimulator, Transcutaneous Electrical, Aesthetic PurposesNeurology2
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232863000Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.2023-12-13OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850035134368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850035134368008500351343688500351343680850035134368

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
00731093153129CurrentBody Skin™MZ-07M2026-06-27
00850079561014CurrentBody Skin™ZLD-72B2026-06-27
00860011935582CurrentBody Skin™MZ-07AM2026-06-27
00860011935599CurrentBody Skin™MZ-07AL2026-06-27
06970006973285CurrentBody Skin™MZ-07L2026-06-27
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

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