FDA.reportPublic FDA data

Photonica Professional

Primary DI
00860925000307
Brand
Photonica Professional
Company
PHOTONICA USA, LLC
Model
60001
Catalog number
60001
Device description
Photonica Professional, Red Light (635 nm)
Published
2016-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860925000307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860925000307008609250003078609250003070860925000307

GMDN Terms#

Term, Definition table
TermDefinition
Low-intensity laser fat liquefaction systemAn assembly of devices designed for the noninvasive application of low-level laser energy [low-level laser therapy (LLLT)] to liquefy (emulsify) subcutaneous and visceral adipose tissue (fat) for cosmetic/aesthetic (e.g., body contouring, circumference reduction) and medical (e.g. weight-loss, lipid reduction) applications. It is a mains electricity (AC-powered) system, mobile on wheels, which incorporates laser diode modules on adjustable arms, a control monitor, and software. It is an independent, primary device which may be used as an adjunct modality in conjunction with liposuction and surgical techniques as a secondary function.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131141859
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860925000338UltraSlim Digital60008600082021-01-04
00860925000345UltraSmooth Digital60009600092021-01-04
00860925000314Cellulize60002600022020-01-17

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