FDA.report

Picasso Tips_400um diam_10mm long

Primary DI
00872320004194
Brand
Picasso Tips_400um diam_10mm long
Company
CAO GROUP, INC.
Model
03809
Device description
Picasso Optical Fiber Tip; 400um diameter; 10mm long. For use with the Picasso family of diode lasers.
Published
2018-09-17
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

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00872320004194PackageGS125In Commercial Distribution
00872320004361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320004194008723200041948723200041940872320004194
00872320004361008723200043618723200043610872320004361

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
866-999-2635support@amdlasers.info

Regulatory Flags

DUNS number
102422578
Device count
1
DM exempt
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00872320006761Monet + Curing Laser001-001232026-02-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320006471Hubble Digital Vision005-001092024-01-22
00872320005610Monet Curing Laser001-001052020-12-14
00872320005627Monet Curing Laser Battery Pack001-001062020-12-14
00872320005634Monet Curing Laser Large Glasses001-001072020-12-14
00872320005641Monet Curing Laser Small Glasses001-001082020-12-14
00872320005665Monet Curing Laser Charging Stand001-001102020-12-14
00872320005948Monet Curing Laser Barrier Sleeve048622020-12-14
00872320005542Aegis Personal Protective Suit005-000812020-05-04
00872320005559Aegis Personal Protective Suit005-000822020-05-04
00872320005535Aegis Personal Protective Suit005-000832020-05-04
00872320005368Aegis Personal Protective Suit005-000722020-04-29
00872320005375Aegis Personal Protective Suit005-000732020-04-29
00872320005382Aegis Personal Protective Suit005-000742020-04-29
00872320005399Aegis Personal Protective Suit005-000752020-04-29
00872320005405Aegis Personal Protective Suit005-000762020-04-29
00872320005412Aegis Personal Protective Suit005-000772020-04-29
00872320005429Aegis Personal Protective Suit005-000782020-04-29

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08052286590500LASER THERMAL THERAPY KIT S EELESTA SPAGEX2026-03-24
08052286590517LASER THERMAL THERAPY KIT L EELESTA SPAGEX2026-03-24
06975617991024DIODE LASER FOR HIAR REMOVALBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617992014Q-SWITCHED ND:YAG LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
06975617993011CO2 FRACTIONAL LASERBEIJING HONKON TECHNOLOGIES CO., LTD.GEX2026-03-23
16977331780080GigaaMedGigaalaser Company Ltd.GEX2026-03-19
02816901023318NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
02816901024032NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
01816901024156NeuLight®Weinert Fiber Optics, Inc.GEX2026-03-12
00860015460615NextGen Aesthetics CO2T AESTHETICS LLCGEX2026-03-12
00860015460639NextGen Aesthetics LHRT AESTHETICS LLCGEX2026-03-12
08034108512877TORODEKA M.E.L.A. SRLGEX2026-03-11
00850069558574Lithoblast Single-Use Holmium Laser FibersDAWELL MEDICAL, LLCGEX2026-03-10
00850069558109Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558116Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558123Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558550Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558567Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558581Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558598Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558604Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558611Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558628Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558635Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558642Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558659Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558666Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558673Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558680Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02
00850069558697Lithoblast Single-Use Holmium Laser Fibers DAWELL MEDICAL, LLCGEX2026-03-02