Zolar

Primary DI
00628055817048
Brand
Zolar
Company
Zolar Technology & Mfg Co. Inc
Model
Photon EXE Plus
Device description
The Photon Series Dental Diode Lasers (Photon EXE / Photon EXE Plus) are surgical devices at the cutting edge of technology, designed for a wide variety of oral soft tissue procedures. Photon Series Diode Lasers utilize a solid-state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch. This is a prescription device that is indicated for professional use only by licensed medical and dental practitioners. The use of this device requires proper clinical and technical training.
Published
2026-04-09
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K122020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122020000PHOTON PHOTON PLUSZolar Technology & Mfg Co., Inc.2013-06-05GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628055817048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628055817048006280558170486280558170480628055817048

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.

Regulatory Flags#

DUNS number
250916892
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055817031ZolarPhoton EXE2026-04-09
00628055817000ZolarPhoton2016-08-31
00628055817017ZolarPhoton Plus2016-08-31

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