FDA.reportPublic FDA data

UltraSmooth Digital

Primary DI
00860925000345
Brand
UltraSmooth Digital
Company
PHOTONICA USA, LLC
Model
60009
Catalog number
60009
Device description
UltraSmooth Digital, Green Light (532nm)
Published
2021-01-04
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
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
K202361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202361000UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC2020-12-18OLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860925000345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860925000345008609250003458609250003450860925000345

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
00860925000314Cellulize60002600022020-01-17
00860925000307Photonica Professional60001600012016-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00860925000314CellulizePHOTONICA USA, LLCOLI2020-01-17
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