FDA.reportPublic FDA data

Omni Laser

Primary DI
16976855557505
Brand
Omni Laser
Company
Shanghai Omni Laser Skinology Co., Ltd.
Model
KDT750
Device description
The Painless IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 530nm to 950nm. The Painless IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.
Published
2024-01-01
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16976855557505PackageGS11Not in Commercial Distribution
06976855557508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697685555750516976855557505
06976855557508069768555575086976855557508

GMDN Terms#

Term, Definition table
TermDefinition
Intense pulsed light skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
560463241
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
true
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
06976855557508Omni LaserKDT7502024-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970453310022MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06970453310039MONALIZABeijing Sincoheren S&T Development Co.,Ltd.ONF2026-09-24
06973011720158Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., LtdONF2026-08-07
07290019840428Silk'nSilkn Beauty Ltd.ONF2026-05-06
00810060831359Venus Versa PROVenus Concept Inc.ONF2026-04-15
06979922960010MICOWEYMicowey Medical Equipment (Guangxi) Co., LTDONF2026-04-08
00850055552555InBellaMax SystemInbella Medical IncONF2026-03-25
06975617994025MULTIFUNCTIONAL SERIESBEIJING HONKON TECHNOLOGIES CO., LTD.ONF2026-03-23
00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALONF2026-02-18
07898786930047ONE FDAVYDENCE MEDICALONF2026-02-18
00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLONF2025-12-16
07290117772645Black Stellar XPL HPLUMENIS BE LTDONF2025-09-08
07290117772652Stellar XPL Module KitLUMENIS BE LTDONF2025-09-08
07290016633313Plus ApplicatorINMODE M.D LTDONF2025-07-27
08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
06974851083014BVLASERNanjing Bestview Laser S&T Co.,Ltd.ONF2024-11-27
06976573489105BilensShanghai Bele Medical Technology Co., Ltd.ONF2024-11-24
07290016681093iProEliteFORMATK SYSTEMS LTDONF2024-10-15
06928258000891GSDShenzhen GSD Tech Co., Ltd.ONF2024-09-30
06977620360019ZHEONEHebei Zhemai Technology Co., Ltd.ONF2024-09-19
08034108512464PRISMADEKA M.E.L.A. SRLONF2024-09-17
07290019863144Lumecca PeakINMODE M.D LTDONF2024-08-15
07290019863151Lumecca PeakINMODE M.D LTDONF2024-08-15
00850033906004XLase PlusBIOTEC ITALIA SRLONF2024-07-29