FDA.reportPublic FDA data

Emvera

Primary DI
00863267000318
Brand
Emvera
Company
EMVERA TECHNOLOGIES, LLC
Model
Diolux Hand piece
Device description
Hand piece to be used with the Emvera Diolux Hair Removal Laser
Published
2016-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K123257000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123257000EMVERA DIOLUXEmvera Technologies, Inc.2012-12-14GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863267000318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863267000318008632670003188632670003180863267000318

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

Contacts#

Phone, Email table
PhoneEmail
1-888-886-8402info@emvera.com

Regulatory Flags#

DUNS number
079501638
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863267000301EmveraDiolux 2016-11-28

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Primary DI, Brand, Company table
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