FDA.reportPublic FDA data

Diode Laser Tips

Primary DI
00647529003404
Brand
Diode Laser Tips
Company
BIOLASE, INC.
Model
Pre-initiated, Surgical, 3-4
Catalog number
7400071
Device description
A single-use fiberoptic pre-initiated tip intended for use with diode laser systems.
Published
2016-11-30
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
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
K121286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121286000EPIC 10Biolase Technology, Inc.2012-09-28GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00647529003404PackageGS130In Commercial Distribution
00647529003343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00647529003404006475290034046475290034040647529003404
00647529003343006475290033436475290033430647529003343

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Millimeter
Outer Diameter300Micrometer

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
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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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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