FDA.reportPublic FDA data

AMD LASERS Bendable Disposable Tips (Assortment of 25)

Primary DI
00851759007020
Brand
AMD LASERS Bendable Disposable Tips (Assortment of 25)
Company
AMD Lasers
Model
TIP25
Catalog number
TIP25
Device description
Bendable disposable tips (assortment of 25 tips) for use with AMD LASERS' Picasso Line of Soft-Tissue Dental Lasers. Contains ten (10) 400um core diameter 5mm length tips, ten (10) 400um core diameter 10mm length tips, and five (5) 300um core diameter 10mm length tips. All tips are pre-bent to 60 degree angle.
Published
2016-09-20
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851759007020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851759007020008517590070208517590070200851759007020

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
Angle60degree

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-999-2635support@amdlasers.com

Regulatory Flags#

DUNS number
080354039
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851759007006Picasso Plus Dental Diode LaserP810PPLUS2016-09-20
00851759007013Picasso Lite Plus Dental Diode LaserPL810PLPLUS2016-09-20
00851759007037Bendable Disposable Tips (Box of 25) 400um, 60 degree, 5mmTIP4006005TIP40060052016-09-20
00851759007044Bendable Disposable Tips (Box of 25) 400um, 60 degree, 10mmTIP4006010TIP40060102016-09-20
00851759007051Bendable Disposable Tips (Box of 25) 300um, 60 degree, 5mmTIP3006005TIP30060052016-09-20
00851759007068Bendable Disposable Tips (Box of 25) 300um, 60 degree, 10mmTIP3006010TIP30060102016-09-20
00851759007075Bendable Disposable Tips (Box of 20) 200um, 60 degree, 20mmTIP2006020TIP20060202016-09-20
00851759007082Multi-Tip Handpiece - Picasso Plus (Orange)MTHP-PPLUSMTHP-PPLUS2016-09-20
00851759007099Multi-Tip Handpiece - Picasso Lite Plus (Black)MTHP-PLPLUSMTHP-PLPLUS2016-09-20
00851759007105Quadra TipQTQT2016-09-20
00851759007112Multi-Tip Handpiece - Picasso (Orange)STF400STF4002016-09-20
00851759007129Multi-Tip Handpiece - Picasso Lite (Black)STF200STF2002016-09-20
00851759007136400um Strippable Fiber - FC ConnectionSF400-FCSF400-FC2016-09-20
00851759007143400um Strippable Fiber - Plus SeriesSF400-PLUSSF400-PLUS2016-09-20
00851759007150400um Strippable Fiber - ST ConnectionSF400-STSF400-ST2016-09-20
00851759007167Laser Safety Goggles (Sport Frame)EYEEYE2016-09-20
00851759007174Laser Safety Goggles (fit-over frame)EYEFEYEF2016-09-20

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Primary DI, Brand, Company table
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08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16