iLase Handpiece

Primary DI
00647529002308
Brand
iLase Handpiece
Company
BIOLASE, INC.
Model
iLase
Device description
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.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093852000EZLASE 3 LASER SYSTEMBiolase Technology, Inc.2010-03-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647529002308PackageGS11In Commercial Distribution
00647529002292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529002308006475290023086475290023080647529002308
00647529002292006475290022926475290022920647529002292

GMDN Terms#

Term, Definition table
TermDefinition
Dental diode laser systemA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-321-6717Diodeservice@biolase.com

Regulatory Flags#

DUNS number
152165700
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00647529004722Waterlase iPlus Dental Laser SystemAll tissue YSGG dental laser system, red SG27200854-222025-01-31
00647529004777Waterlase iPlus Dental Laser SystemAll tissue YSGG dental laser system, platinum SG27200854-292025-01-31
00647529001042Waterlase Laser TipsRFT2-216201043,7230019,72008202016-09-16
00647529003442Waterlase Laser Tips Side Firing Tips6201472.72008672017-04-17
00647529003602Waterlase Laser Tips Side Firing Tips, SFT8-186201735,7230002,72300032017-10-01
00647529003732Waterlase Laser TipsLaserFresh Sapphire Tip, Single Bagged Tip, Single6200011,72300042023-08-01
00647529004074EdgeProTip Assembly - Two-21mm, WL JUNO6200184,7230012,72300312023-06-19
00647529004081EdgeProTip Assembly - Two-17mm, WL JUNO6200181,7230011,72300302023-06-19
00647529004098EdgeProTip Assembly - Three-10mm, WL JUNO6200152,7230008,72300132023-06-19
00647529004104EdgeProTip Assembly - One-21 mm, WL JUNO6200153,7230009,72300212023-06-19
00647529004111EdgeProTip Assembly - One-25 mm, WL JUNO6200154,7230010,72300222023-06-19
00647529004265Waterlase Laser TipsTip, MZ6-17mm6200824,72300142023-06-12
00647529003787Waterlase iPlus Dental Laser SystemLaserFresh Accessory Kit Bundle72200052023-08-01
00647529004296EdgeProTip Assembly - One-17 mm62001552023-06-19
00647529003763Waterlase Laser TipsRFT2-176201042,7230007,72300182023-06-12
00647529003800Waterlase Express Waterlase Express Tip Starter Kit, 37pk72300012023-06-12
00647529000670Waterlase Laser Tips MT4-66200301,72003032016-09-16
00647529001127Waterlase Laser Tips Z2-206000772,70001622016-09-16
00647529001158Waterlase Laser Tips Z2-286000774,70001652016-09-16
00647529001189Waterlase Laser Tips Z3-146000781,70001712016-09-16

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