FDA.reportPublic FDA data

InPulse Dental Laser

Primary DI
00860367000309
Brand
InPulse Dental Laser
Company
INCISIVE, LLC
Model
InPulse Touch 120
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

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
K131805000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131805000INPULSE LASERIncisive, Inc.2013-07-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860367000309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860367000309008603670003098603670003090860367000309

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
510-669-9401myessik@gmail.com

Regulatory Flags#

DUNS number
009493060
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860367000316InPulse Dental LaserInPulse Touch 1202016-12-12

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Primary DI, Brand, Company table
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08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
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