FDA.reportPublic FDA data

iLase Handpiece

Primary DI
00647529002551
Brand
iLase Handpiece
Company
Biolase, Inc.
Model
iLase Refurbished
Device description
iLase Handpiece is a diode laser handpiece designed for a variety of dental soft tissue procedures. The packaging contains one handpiece and accessories such as diode laser tips, tip cleaning kit, tip initiation kit and 2 extra handpiece cover grips. iLase charging station is not included. The handpiece is a reusable device with a removable cover which requires sterilization prior to each patient use.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00647529002551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529002551006475290025516475290025510647529002551

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
Kit
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00647529001196Waterlase Laser Tips Z3-186000782,70001722016-09-16
00647529001202Waterlase Laser Tips Z3-206000783,70001732016-09-16

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