MICOWEY

Primary DI
06979922960010
Brand
MICOWEY
Company
Micowey Medical Equipment (Guangxi) Co., LTD
Model
MMABM-1
Device description
Intense Pulsed Light Therapy Device
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K251545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251545000Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.2025-09-04ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979922960010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979922960010069799229600106979922960010

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.

Regulatory Flags#

DUNS number
631759374
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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