FDA.reportPublic FDA data

capillus

Primary DI
06950940802278
Brand
capillus
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-804
Published
2024-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
06950940802261PrimaryGS10
06950940802278Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950940802261069509408022616950940802261
06950940802278069509408022786950940802278

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528161684
Device count
201
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06950940803046CVSHealthAST-805B2026-11-04
06950940802971N/AAST-805B2026-07-30
06950940802810N/AAST-6462025-12-19
06950940802827N/AAST-6222025-12-20
06950940802773N/AAST-2011A2025-12-10
06950940802766N/AAST-804A2025-09-19
06950940802698N/AAST-8042025-07-21
06950940802667N/AAST-300C2025-06-20
06950940802582N/AAST-802B2025-05-30
06950940802612N/AAST-2012A2025-05-30
06950940802568N/AAST-300W2025-04-25
06950940802575N/AAST-300W2025-04-25
06950940802490capillusAST-805A2025-03-15
06950940802506capillusAST-805A2025-03-15
06950940802476AuxolievAST-6032025-03-10
06950940802483AuxolievAST-6032025-03-10
06950940801264OSITOAST-300H2025-02-25
06950940801271OSITOAST-300H2025-02-25
06950940802452N/AAST-300H2025-02-15
06950940802469N/AAST-300H2025-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284505988VogueNow LuminX ProBRAIN TIDES PTE. LTD.OLP2026-11-05
00199874726069VogueNow LuminX ProBRAIN TIDES PTE. LTD.OLP2026-11-05
06950940803046CVSHealthShenzhen Osto Technology Co.,Ltd.OLP2026-11-04
00622356703987Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00855264008695CamarAura MedicalOLP2026-10-22
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOLP2026-10-19
00810045461632CapillusCAPILLUS, LLCOLP2026-10-19
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOLP2026-10-01
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOLP2026-09-21
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27
00860016300309LMNTXPLR LTDOLP2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OLP2026-08-14
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOLP2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OLP2026-07-30
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600036BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
06980105600043BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OLP2026-07-16
00860015912503BOB AND BRADAmazing Impulse, LLCOLP2026-07-06
00810140063090RenphoJoicom CorporationOLP2026-06-23
00622356646390Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356663076Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669351Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02
00622356669597Shark CryoGlowSharkNinja Operating LLCOLP2026-06-02