AccessGUDID - DEVICE: Renuva 1550 (06972978060031)

GUDID

Device Identifier (DI) Information

Brand Name: Renuva 1550
Version or Model: WFB-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F700001
Company Name: Wingderm Electro-Optics Ltd.

Primary DI Number: 06972978060031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554510960 *Terms of Use

Device Description: Medical Non-ablative Fractional Laser Systems

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62362	Thermo-mechanical skin surface treatment system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ONG	Powered Laser Surgical Instrument With Microbeam\Fractional Output

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192350	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 32be4118-062b-4d33-b610-6d716117dd0d
Public Version Date: November 24, 2020
Public Version Number: 1
DI Record Publish Date: November 16, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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