FDA.reportPublic FDA data

Renuva 1550

Primary DI
06972978060031
Brand
Renuva 1550
Company
Wingderm Electro-Optics Ltd.
Model
WFB-01
Catalog number
F700001
Device description
Medical Non-ablative Fractional Laser Systems
Published
2020-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192350000Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics , Ltd.2020-04-30ONG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972978060031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972978060031069729780600316972978060031

GMDN Terms#

Term, Definition table
TermDefinition
Thermo-mechanical skin surface treatment systemA mains electricity (AC-powered) portable assembly of devices intended to be used for skin resurfacing and rejuvenation via application of pulsed thermal and mechanical energy (i.e., it does not emit radiation such as laser or radio-frequency energy) on the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles). It consists of a control/display unit, a handpiece, and a removable heat-conductive handpiece tip made of metal, typically with small pointed pins designed to make repeated fractional contact with the skin surface.

Regulatory Flags#

DUNS number
554510960
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972978060017Lasermach PROWLA-01L2000012020-11-16
06972978060024Lasermach PRO Handpiece WLA-012020-11-16
06972978060116Lasermach WLA-022026-04-20
06972978060123Lasermach WLA-022026-04-20
06972978060130Lasermach WLA-022026-04-20
06972978060147Lasermach WLA-022026-04-20
06972978060154Lasermach WLA-022026-04-20
06972978060161Lasermach WLA-022026-04-20
06972978060178Lasermach WLA-022026-04-20
06972978060185Lasermach WLA-022026-04-20
06972590500021Lasermach PRO HandpieceWLA-012019-12-16
16972590500028Lasermach PRO HandpieceWLA-012019-12-02
06972590500014Lasermach WLA-01L2000012019-11-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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