FDA.reportPublic FDA data

Waterlase Laser Tips

Primary DI
00647529000656
Brand
Waterlase Laser Tips
Company
Biolase, Inc.
Model
MZ3-25
Device description
A single-use fiberoptic accessory intended for use with Waterlase laser delivery systems.
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K101658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101658000WATERLASE MD TURBO PLUS MODEL 7200XXXBiolase Technology, Inc.2010-08-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647529001752PackageGS15In Commercial Distribution
00647529000656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529001752006475290017526475290017520647529001752
00647529000656006475290006566475290006560647529000656

GMDN Terms#

Term, Definition table
TermDefinition
Dental solid-state laser systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter320Micrometer

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
152165700
Device count
1
DM exempt
true
Lot or batch
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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