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
OTC
false
Sterile
false
Single use
false

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 system, mobileAn 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.

Regulatory Flags#

DUNS number
131141859
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
00860925000338UltraSlim Digital60008600082021-01-04
00860925000345UltraSmooth Digital60009600092021-01-04
00860925000314Cellulize60002600022020-01-17

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