FDA.reportPublic FDA data

Capillus

Primary DI
00810045461632
Brand
Capillus
Company
CAPILLUS, LLC
Model
RB-071
Device description
LED face mask device for use on the face that produces red light to diminish the appearance of fine lines and wrinkles and blue light for the treatment of mild to moderate acne vulgaris.
Published
2026-10-19
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

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
K253712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253712000LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)Shenzhen Rainbow Technology Co., Ltd.2026-01-23OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045461632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045461632008100454616328100454616320810045461632

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.

Regulatory Flags#

DUNS number
079813345
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00810045461427CapillusAST-8042025-01-21
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOLP2026-10-01
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOHS2026-09-21
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOLP2026-08-17
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
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00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
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06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16