FDA.report

K2 MOBILE

Primary DI
08800079000008
Brand
K2 MOBILE
Company
HULASER, Inc.
Model
K2 MOBILE
Device description
K2 MOBILE LASER IS INTENDED FOR USE BY DENTISTS FOR EXCISION, INCISION, VAPORIZATION, ABLATION AND COAGULATION OF ORAL SOFT TISSUE PROCEDURES, INCLUDING TOOTH WHITENING AND THE TEMPORARY RELIEF OF PAIN.
Published
2022-06-16
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
false

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K200693000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K200693000K2 MOBILEHulaser, Inc.2020-11-19GEX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800079000008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800079000008088000790000088800079000008

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+82230125678info@hulaser.com

Regulatory Flags

DUNS number
688409662
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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