FDA.reportPublic FDA data

Focus Medical

Primary DI
00865601000336
Brand
Focus Medical
Company
FOCUS MEDICAL, LLC
Model
CO2 Laser
Published
2018-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONGPowered Laser Surgical Instrument With MicrobeamFractional OutputGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865601000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865601000336008656010003368656010003360865601000336

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
841432912
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00865601000350Focus MedicalIPL2020-03-17
00865601000312Focus MedicalNaturaLaseQS2018-11-30
00865601000343Focus MedicalErbium Laser2018-11-30
00865601000329Carbon Wave PatchCWP2022-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800020109576FootswitchJeisys Medical Inc.ONG2026-07-16
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08800020109668Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.ONG2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.ONG2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.ONG2026-07-16
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06974077940023MLKJWeifang Mingliang Electronics Co., Ltd.ONG2025-09-17