FDA.reportPublic FDA data

CVSHealth

Primary DI
06950940803046
Brand
CVSHealth
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-805B
Published
2026-11-04
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
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
00050428418833PackageGS11In Commercial Distribution
06950940803046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00050428418833000504284188330504284188330050428418833
06950940803046069509408030466950940803046

Regulatory Flags#

DUNS number
528161684
Device count
1
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
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
06950940802391N/AAST-805A2025-02-10

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
06980597240017nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
06980597240024nephaeaDongguan Yijiaming Technology Co., LtdOHS2026-10-28
00622356703987Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356703987Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356712651Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOLP2026-10-26
00622356739603Shark CryoGlowSharkNinja Operating LLCOHS2026-10-26
00855264008695CamarAura MedicalOLP2026-10-22
00855264008695CamarAura MedicalOHS2026-10-22
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOHS2026-10-19
00622356757744Shark™ CryoGlowSharkNinja Operating LLCOLP2026-10-19
00810045461632CapillusCAPILLUS, LLCOLP2026-10-19
00810045461632CapillusCAPILLUS, LLCOHS2026-10-19
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.,LTDOLP2026-08-27
06974639600501IBORRIASHENZHEN BORRIA TECHNOLOGY CO.,LTDOHS2026-08-27
00860016300309LMNTXPLR LTDOHS2026-08-17
00860016300309LMNTXPLR LTDOLP2026-08-17