AccessGUDID - DEVICE: iLase Diode Laser System (00647529002322)

GUDID

Device Identifier (DI) Information

Brand Name: iLase Diode Laser System
Version or Model: iLase
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7400040-01
Company Name: Biolase, Inc.

Primary DI Number: 00647529002322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: iLase Diode Laser System is designed for a variety of dental soft tissue procedures. The iLase system consists of one iLase handpiece and the iLase charging station used for charging and storing the handpiece and replacement batteries. Other systems components include protective eyewear, rechargeable batteries, charging station power supply, handpiece cover grips, laser tips and a tip cleaning kit. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.

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?
60340	Dental diode laser system	A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093852	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: 68e91b11-15a4-40ed-81d5-6fb79c37efbb
Public Version Date: June 12, 2023
Public Version Number: 7
DI Record Publish Date: September 22, 2016