FDA.reportPublic FDA data

Tanda

Primary DI
00806248005186
Brand
Tanda
Company
Tanda Beauty Canada, Inc
Model
Series 4
Catalog number
HU-FG00961
Device description
Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Published
2017-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080591000TANDA SKINCARE SYSTEM, MODEL: PTSCSPharos Life Corporation2008-11-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806248005183PackageGS13In Commercial Distribution
20806248005180PackageGS18In Commercial Distribution
00806248005186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080624800518310806248005183
2080624800518020806248005180
00806248005186008062480051868062480051860806248005186

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
248047115
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00806248005322IluminageHU-FG00851USHU-FG00851US2016-10-19
00806248006336IluminageHU-CO00621HU-CO006212016-10-19
10806248005329IluminageHU-FG00851USHU-FG00851US2016-10-19
10806248006333IluminageHU-CO00621HU-CO006212016-10-19
00806248007296IluminageHU-FG017512017-07-10
00806248004936TandaSeries 4HU-FG006312017-10-02
00806248004929TandaSeries 4HU-FG006212017-10-02
20806248004930TandaSeries 4HU-FG006312017-10-02
20806248005180TandaSeries 4HU-FG009612017-10-02
00806248006114MeSeries 14HU-FG012712016-09-24
00806248007555MeSeries 14HU-FG018712017-08-23
20806248006118MeSeries 14HU-FG012712016-09-24
00806248006459MeSeries 15HU-FG012812016-09-24
00806248007241MeSeries 14HU-FG017212017-07-10
00806248007289MeSeries 14HU-CO008212017-07-25
00806248007425MeSeries 15HU-FG018212017-07-10
00806248007432MeSeries 14HU-CO008712017-07-11
00806248007463MeSeries 15HU-CO009012017-07-11
20806248007559MeSeries 14HU-FG018712017-08-23
00806248007562MeSeries 15HU-FG018812017-08-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
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08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16