FDA.reportPublic FDA data

Picasso Pro Pre-initiated Laser Tip, Variety Pack

Primary DI
00872320007195
Brand
Picasso Pro Pre-initiated Laser Tip, Variety Pack
Company
CAO GROUP, INC.
Model
002-00492
Device description
Picasso Pro Pre-initiated Optical Fiber Tip, Variety Pack
Published
2026-08-03
Public version status
New
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
NVKLaser, Dental, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K254197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K254197000Picasso Pro Diode Laser (002-00460)CAO Group, Inc.2026-03-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00872320007195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00872320007195008723200071958723200071950872320007195

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
Liquid Chemical

Contacts#

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

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
true
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
00872320006846LEAP Laser Delivery Tip050832026-04-10
00872320006853Picasso Pro Pre-initiated Laser Tip, 300um, 5mm053792026-04-10
00872320006860Picasso Pro Pre-initiated Laser Tip, 300um, 10mm051932026-04-10
00872320006877Picasso Pro Pre-initiated Laser Tip, 400um, 5mm053802026-04-10
00872320006884Picasso Pro Pre-initiated Laser Tip, 400um, 10mm051942026-04-10
00872320005825LEAP Cavity Cleansing Solution006-002722026-04-10
00872320006440Picasso Pro Diode Laser002-004602026-04-10
00872320006617Picasso Pro Pre-initiated Laser Tip, Variety Pack002-004802026-04-10
00872320006891Picasso Pro Disposable Therapy Tip, Straight052212026-04-10
00872320006907Picasso Pro Disposable Therapy Tip, Curved052222026-04-10
00872320006761Monet + Curing Laser001-001232026-02-10
00872320004477Ultimate Contour Mini005-000362019-09-06
00872320003364Pilot Diode Laser 600um Tip030932016-11-10
00872320003418Pilot Straight Tip006682016-11-10
00872320003425Pilot 60° Tip006692016-11-10
00872320003456Pilot Diode Laser030922016-11-10
00872320006457Acuity Direct X-Ray Photon Detection005-001232024-02-19
00872320006464Acuity Direct X-Ray Photon Detection005-002142024-02-19
00872320000127BlissBond Intro Kit006-00044006-000442016-11-10
00872320000141BlissEtch Intro Kit006-00029006-000292016-11-10

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07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
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