FDA.reportPublic FDA data

B.Light Clear Evo

Primary DI
07640161460195
Brand
B.Light Clear Evo
Company
Bemer Int. AG
Model
BEMER Therapy System Evo
Catalog number
434500
Published
2025-03-05
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
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223919000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223919000B.Light Clear Evo and B.Light Restore EvoBemer Int AG2023-09-23OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640161460195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640161460195076401614601957640161460195

GMDN Terms#

Term, Definition table
TermDefinition
Light-energy skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated light energies [e.g., fluorescent, ultraviolet B (UVB)] used for ablative and non-ablative treatment of skin conditions (e.g., acne, psoriasis, vascular lesions, wrinkles, large pores). This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
448002860
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640161464124Light Pack EvoBEMER Therapy System Evo4150202025-03-24
07640161460201B.Light Restore EvoBEMER Therapy System Evo4346002025-03-05
07640161460904BEMER Classic-Set Evo (B.Body)BEMER Therapy System Evo4143202025-03-24
07640161460959BEMER Classic-Set Evo (B.Bed)BEMER Therapy System Evo4144202025-03-24
07640161464100BEMER Basic-Set EvoBEMER Therapy System Evo4141202025-03-24
07640161464117BEMER Premium-Set EvoBEMER Therapy System Evo4142202025-03-24
07640161460065B.Pad EvoBEMER Therapy System Evo 4341002025-03-05
07640161460072B.Body EvoBEMER Therapy System Evo4343002025-03-05
07640161460089B.Bed EvoBEMER Therapy System Evo4344002025-03-05
07640161460096B.Sit EvoBEMER Therapy System Evo4342002025-03-05
07640161460188B.Spot EvoBEMER Therapy System Evo4340002025-03-05
07640161460706B.Box EvoBEMER Therapy System Evo4240202025-03-05
07640161460218Bemer Therapy SystemB.SIT4314002021-02-11
07640161461086Bemer Therapy SystemB.BODY Professional4302012021-02-11
07640161461055BEMER Therapy SystemsProfessional4102012017-05-03
07640161462014BEMER Therapy SystemsB.BOX Classic4201002017-05-03
07640161461017BEMER Therapy SystemsB.BOX Classic4201002017-05-03
07640161461048BEMER Therapy SystemsB.BOX Professional4202002017-05-03

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06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOHS2026-07-06
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00810140063090RenphoJoicom CorporationOLP2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
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00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
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00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
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