Cellulize

Primary DI
00860925000314
Brand
Cellulize
Company
PHOTONICA USA, LLC
Model
60002
Catalog number
60002
Device description
Cellulize, Green Light (532nm)
Published
2020-01-17
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
OLIFat Reducing Low Level Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLIFat Reducing Low Level LaserGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180338000CellulizeWard Photonics, LLC2018-09-21OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860925000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860925000314008609250003148609250003140860925000314

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
00860925000307Photonica Professional60001600012016-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858985006391Erchonia CLXERCHONIA CORPORATION, LLCOLI2026-07-21
06973337180018Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
06973337180025Led Light Phototherapy BedShenzhen Suyzeko LimitedOLI2026-05-09
00850075326006CellumaBiophotas, Inc.OLI2025-07-24
00850075326044CellumaBiophotas, Inc.OLI2025-07-24
06970006971212EnergyLoungerShenzhen Kaiyan Medical Equipment Co,. LtdOLI2025-06-28
04260489020425R11 Air KBL GmbHOLI2025-06-25
00858985006292Erchonia Zerona VZ8ERCHONIA CORPORATION, LLCOLI2025-02-25
00850523007594CellumaBiophotas, Inc.OLI2024-12-23
00850523007761CellumaBiophotas, Inc.OLI2024-12-23
00850523007891CellumaBiophotas, Inc.OLI2024-12-23
00850523007938CellumaBiophotas, Inc.OLI2024-12-23
00850523007709CellumaBiophotas, Inc.OLI2024-12-20
00858985006261Erchonia Zerona Z-BedERCHONIA CORPORATION, LLCOLI2022-10-31
00860925000338UltraSlim DigitalPHOTONICA USA, LLCOLI2021-01-04
00860925000345UltraSmooth DigitalPHOTONICA USA, LLCOLI2021-01-04
00860925000307Photonica ProfessionalPHOTONICA USA, LLCOLI2016-12-21
00086092500307Photonica ProfessionalWARD PHOTONICS LLCOLI2016-12-21
00858985006018EmeraldERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006070VerjuERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006100Zerona 2.0ERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006117Zerona ADERCHONIA CORPORATION, LLCOLI2016-09-24
00858985006124Zerona Z6ERCHONIA CORPORATION, LLCOLI2016-09-24