AccessGUDID - DEVICE: DentaLaze Kit (E235DL0010)

GUDID

Device Identifier (DI) Information

Brand Name: DentaLaze Kit
Version or Model: DL001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DL001
Company Name: SHOFU DENTAL CORPORATION

Primary DI Number: E235DL0010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 054618202 *Terms of Use

Device Description: DentaLaze Diode Laser Kit with the following content: Laser Handpiece (Main Control & Battery), 2 goggles, 1 laser shield, 5 fiber tips, 50 laser sheaths, 1 charging stand, 1 power adapter, IFU, Box Oversleeve, Labels: box, fiber tips, charging stand, Danger sign

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?
60341	General/multiple surgical diode laser system	An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NVK	Laser, Dental, Soft Tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201387	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 900df90e-b156-4846-9ff8-eac8f15d3c1b
Public Version Date: May 22, 2025
Public Version Number: 2
DI Record Publish Date: June 06, 2023