FDA.reportPublic FDA data

Capillus

Primary DI
00810045461427
Brand
Capillus
Company
CAPILLUS, LLC
Model
AST-804
Device description
Red and blue light therapy device to reduce the appearance of fine lines and wrinkles and treat mild to moderate acne vulgaris.
Published
2025-01-21
Public version status
New
Distribution status
Not 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
K213056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213056000LED Facial MaskShenzhen Osto Technology Company Limited2022-07-07OLP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045461427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045461427008100454614278100454614270810045461427

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079813345
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
00810045461571CapillusTri Spectrum2026-03-01
00810045461533CapillusMD Duo2025-09-03
00810045461564CapillusRx Duo2025-09-03
00810045461458CapillusSpectrum MD2024-12-19
00810045461526CapillusPro S22025-08-19
00810045461410CapillusSpectrum2024-10-16
00853327006763CapillusX+, HairClub X Plus Laser Cap2023-01-24
00810045461021CapillusMD2023-04-05
00810045460901CapillusOne2022-12-29
00810045460918CapillusPlus S12022-12-29
00810045460956CapillusFocal Temple2022-12-29
00810045460963CapillusFocal Crown2022-12-29
00810045460970CapillusFocal Medial2022-12-29
00810045461007CapillusPro S12022-12-29
00810045461014CapillusOne S2022-12-29
00853327006411CapillusRx2022-12-29
00853327006527Capillusultra2022-12-29
00853327006534Capillusultra XL2022-12-29
00853327006541Capillusplus XL2022-12-29
00853327006558Capillusplus2022-12-29

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Primary DI, Brand, Company table
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00622356663076Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356706926Shark CryoGlowSharkNinja Operating LLCOHS2026-06-02
10622356642801Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
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05060534511231PRIORI Next Generation LED FacemaskI-SMART DEVELOPMENTS LIMITEDOHS2026-03-31
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16978368600167LED Light Therapy MaskShenzhen Rainbow Technology Co.,LtdOLP2026-02-06
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