FDA.reportPublic FDA data

N/A

Primary DI
06950940802407
Brand
N/A
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-805A
Published
2025-02-10
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, 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
06950940802391PrimaryGS10
06950940802407Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950940802391069509408023916950940802391
06950940802407069509408024076950940802407

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528161684
Device count
1000
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.OHS2026-11-05
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
06980597240017nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
06980597240024nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
00622356703987Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00855264008695CamarAura MedicalOHS2026-10-22
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOHS2026-10-19
00810045461632CapillusCAPILLUS, LLCOHS2026-10-19
04897111807354Project E BeautyDUPLEX INTERNATIONAL TRADING LIMITEDOHS2026-10-01
10622356707562Shark™ CryoGlowSharkNinja Operating LLCOHS2026-09-21
06974639600495IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOHS2026-08-17
06980299090002ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090019ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
06980299090026ESTHELAShaoxing Chongsu E-Commerce Co., Ltd.OHS2026-08-14
09361725025404BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
09361725025411BON CHARGELight Tree Ventures Europe B.V.OHS2026-08-11
05060534511521ELEMIS Red Light MaskI-SMART DEVELOPMENTS LIMITEDOHS2026-08-07
00622356746410Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
00622356746526Shark™ CryoGlow Plus™SharkNinja Operating LLCOHS2026-08-01
06950940802971N/AShenzhen Osto Technology Co.,Ltd.OHS2026-07-30
00850001456814Velora REDOmm Imports Inc.OHS2026-07-26
06980105600012BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16
06980105600029BestqoolDongguan Laiguang Electronic Technology Co.,Ltd.OHS2026-07-16