AccessGUDID - DEVICE: Waterlase iPlus Dental Laser System (00647529004388)

GUDID

Device Identifier (DI) Information

Brand Name: Waterlase iPlus Dental Laser System
Version or Model: All tissue YSGG dental laser system , bright lime premier
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7200854-205
Company Name: Biolase, Inc.

Primary DI Number: 00647529004388
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 152165700 *Terms of Use

Device Description: An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to 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?
47880	Dental solid-state laser system	A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210183	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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46f79a90-6381-40bc-8858-a30152631251
Public Version Date: March 01, 2024
Public Version Number: 1
DI Record Publish Date: February 22, 2024