FDA.reportPublic FDA data

Umitec

Primary DI
06950940802377
Brand
Umitec
Company
Shenzhen Osto Technology Co.,Ltd.
Model
AST-805B
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
06950940802377PrimaryGS10
06950940802384Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06950940802377069509408023776950940802377
06950940802384069509408023846950940802384

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture electrical stimulation systemAn electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals.

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
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
06950940802407N/AAST-805A2025-02-10

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