AccessGUDID - DEVICE: Skin Renu Laser (B58613752)

GUDID

Device Identifier (DI) Information

Brand Name: Skin Renu Laser
Version or Model: SRL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13752
Company Name: Tria Laser Inc

Primary DI Number: B58613752
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116909762 *Terms of Use

Device Description: Skin Renu Laser

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):	No
Over the Counter (OTC):	Yes
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?
45221	Dermatological laser beam guiding handpiece	A hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This is a reusable device.	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 [?]
K130459	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: f85e3cfd-d46b-4af2-8c9d-e8f00f8c30f0
Public Version Date: March 03, 2025
Public Version Number: 3
DI Record Publish Date: July 13, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-877-321-8742
Email: customercare@triabeauty.com

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