FDA.reportPublic FDA data

N/A

Primary DI
06950940802438
Brand
N/A
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-804B
Published
2025-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
06950940802438PrimaryGS10
06950940802445Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950940802438069509408024386950940802438
06950940802445069509408024456950940802445

Regulatory Flags#

DUNS number
528161684
Device count
1000
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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.OHS2026-11-05
00199284505988VogueNow LuminX ProBRAIN TIDES PTE. LTD.OLP2026-11-05
00199874726069VogueNow LuminX ProBRAIN TIDES PTE. LTD.OLP2026-11-05
00199874726069VogueNow LuminX ProBRAIN TIDES PTE. LTD.OHS2026-11-05
07640260120501FAQ 401Foreo ABOHS2026-11-05
07640260120518FAQ 402Foreo ABOHS2026-11-05
06950940803046CVSHealthShenzhen Osto Technology Co.,Ltd.OHS2026-11-04
06950940803046CVSHealthShenzhen Osto Technology Co.,Ltd.OLP2026-11-04
06980597240017nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
06980597240024nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
00622356703987Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356703987Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00855264008695CamarAura MedicalOLP2026-10-22
00855264008695CamarAura MedicalOHS2026-10-22
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOLP2026-10-19
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOLP2026-10-19
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOHS2026-10-01
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.,LTDOHS2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOLP2026-08-27