WORLD AESTHETIX BROAD PULSED LIGHT

Primary DI
00850062978003
Brand
WORLD AESTHETIX BROAD PULSED LIGHT
Company
WORLD AESTHETIX LLC
Model
WAX161286
Device description
The World Aesthetix Broad Pulsed Light device is indicated for use in surgical, aesthetic applications in permanent hairreduction, reduction of benign pigmented lesions and benign vascular lesions.Permanent hair reduction is defined as the long-term, stable reduction in the number of hairsregrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
Published
2024-06-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161286000IPL Therapy MachineBeijing Adss Development Co., Ltd.2016-08-04ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850062978003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850062978003008500629780038500629780030850062978003

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
931002047
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850062978010NuSkin RF MicroWAX2317492024-12-13

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Primary DI, Brand, Company table
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