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Renuva 1550

FDA UDIEUDAMED

Class II (US FDA UDI)

by Wingderm Electro-Optics Ltd.

Identity

Trade Name
Renuva 1550 FDA UDI
Generic Name
Thermo-mechanical skin surface treatment system FDA UDI
Device Name
Medical Non-ablative Fractional Laser Systems FDA UDI
Model / Reference
WFB-01 FDA UDI
Description
Medical Non-ablative Fractional Laser Systems FDA UDI

Identifiers

Catalog Number
F700001 FDA UDI
Primary DI / UDI-DI
06972978060031 FDA UDI
510(k) Number
K192350 FDA UDI
FDA Product Code
ONG FDA UDI
GMDN Term
Thermo-mechanical skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Thermo-mechanical skin surface treatment system

Renuva 1550 by Wingderm Electro-Optics Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Thermo-mechanical skin surface treatment system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Wingderm Electro-Optics Ltd.

Sources (2)

  • FDA UDI 32be4118-062b-4d33-b610-6d716117dd0d 35 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026