iLase Handpiece - iLase is a small, lightweight, battery-operated - BIOLASE, INC.

Duns Number:152165700

Device Description: iLase is a small, lightweight, battery-operated diode laser handpiece intended for a varie iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of dental soft-tissue procedures such as incision, excision, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva, as well as laser periodontal procedures. The laser has a wavelength of 940nm. The laser energy is delivered to the treatment site via a single-use laser tip attached to the handpiece.The handpiece is reusable with a removable cover which requires sterilization prior to each patient use. The iLase packaging contains one handpiece and accessories such as laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips.The product is also available as a system packaged with a charging station which is used for charging and storing the iLase and replacement batteries.

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More Product Details

Catalog Number

-

Brand Name

iLase Handpiece

Version/Model Number

iLase

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093852,K093852

Product Code Details

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Device Record Status

Public Device Record Key

9675cf05-1923-437f-80c8-901c84e4f274

Public Version Date

July 29, 2020

Public Version Number

6

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

00647529002308

Quantity per Package

1

Contains DI Package

00647529002292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"BIOLASE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 155