FDA.reportPublic FDA data

Tanda

Primary DI
20806248004930
Brand
Tanda
Company
Tanda Beauty Canada, Inc
Model
Series 4
Catalog number
HU-FG00631
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
10806248004933PackageGS13In Commercial Distribution
20806248004930PackageGS18In Commercial Distribution
00806248004936PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080624800493310806248004933
2080624800493020806248004930
00806248004936008062480049368062480049360806248004936

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248047115
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
false
Expiration date on label
false
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
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
00806248005186TandaSeries 4HU-FG009612017-10-02
00806248004929TandaSeries 4HU-FG006212017-10-02
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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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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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