FDA.reportPublic FDA data

Lasermach PRO Handpiece

Primary DI
16972590500028
Brand
Lasermach PRO Handpiece
Company
Wingderm Electro-Optics Ltd.
Model
WLA-01
Device description
Diode Laser Therapy Systems Handpiece RETIRED
Published
2019-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K191611000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191611000Diode Laser Therapy SystemsWingderm Electro-Optics , Ltd.2019-07-31GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972590500028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697259050002816972590500028

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554477467
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972978060017Lasermach PROWLA-01L2000012020-11-16
06972978060024Lasermach PRO Handpiece WLA-012020-11-16
06972978060116Lasermach WLA-022026-04-20
06972978060123Lasermach WLA-022026-04-20
06972978060130Lasermach WLA-022026-04-20
06972978060147Lasermach WLA-022026-04-20
06972978060154Lasermach WLA-022026-04-20
06972978060161Lasermach WLA-022026-04-20
06972978060178Lasermach WLA-022026-04-20
06972978060185Lasermach WLA-022026-04-20
06972590500021Lasermach PRO HandpieceWLA-012019-12-16
06972590500014Lasermach WLA-01L2000012019-11-01
06972978060031Renuva 1550WFB-01F7000012020-11-16

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