iLase Handpiece

GUDID 00647529002308

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.

BIOLASE, INC.

Dental diode laser system
Primary Device ID00647529002308
NIH Device Record Key9675cf05-1923-437f-80c8-901c84e4f274
Commercial Distribution StatusIn Commercial Distribution
Brand NameiLase Handpiece
Version Model NumberiLase
Company DUNS152165700
Company NameBIOLASE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com
Phone1-800-321-6717
EmailDiodeservice@biolase.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100647529002292 [Primary]
GS100647529002308 [Package]
Contains: 00647529002292
Package: Case [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


[00647529002308]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-08
Device Publish Date2016-09-22

On-Brand Devices [iLase Handpiece ]

00647529002551iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue procedur
00647529002308iLase is a small, lightweight, battery-operated diode laser handpiece intended for a variety of

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