Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code: PDZ

General & Plastic Surgery Medical Laser Products

Definition: For The Temporary Increase Of Clear Nail In Patients With Onychomycosis (e. G. , Dermatophytes Trichophyton Rubrum And T Mentagrophytes, And/or Yeasts Candida Albicans, Etc. ).

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as PDZ

5861Lasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5861Lasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Pre-market Notifications for PDZ

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K150138Aspen Laser Systems Therapy Laser SystemASPEN LASER SYSTEMS, LLC
K123014LITECURE THERAPY SYSTEM MODEL LTS-1500LITECURE, LLC
K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-NFOTONA D.D.
K120938THE PL-1064 LASER SYSTEMSHEAUMANN LASER, INC
K113843FREEDOM ND: YAG LASER SYSTEMLUTRONIC CORPORATION
K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESALMA LASERS INC.
K113702FOTONA XP ND: YAG LASER SYSTEMFOTONA D.D.
K111483JOULE CLEARSENSE LASER SYSTEMSCITON, INC.
K110375BLUESHINE'S GOLD SERIESBLUESHINE SRL
K110370Q-CLEARLIGHT AGE, INC.
K103626CUTERA GENESISPLUS LASER SYSTEMCUTERA, INC.

Global Unique Device Identification Database

00816722023209Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
00816722021205Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
00858985006056Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
00854103007059Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
00854103007035Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
03830054230194Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
08033945934347Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Maude Adverse Events

COOLTOUCHSYNERON MEDICAL LTD.2019-04-05
2018-10-09
2018-06-20
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