Data / Medical devices / Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (PDZ): 14 FDA-registered makers in 7 countries
14 establishments in 7 countries are registered with the FDA to make Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ, Class 2, 21 CFR 878.4810). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on March 9, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PDZ
- Device class
- 2
- Regulation
- 878.4810
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 4 |
| Israel | 1 |
| Slovenia | 1 |
| Canada | 1 |
| Mexico | 1 |
| Brazil | 1 |
Makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alma Lasers Ltd. | CAESAREA Northern, Israel | Manufacturer | 1 | March 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Erchonia Corporation | Fountain Inn, SC, United States | Complaint file establishment, Manufacturer, Remanufacturer | 1 | June 3, 2016 | 0 | 0 | 0 | api.fda.gov |
| Fotona D.O.O. | Ljubljana, Slovenia | Manufacturer | 1 | March 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| LT Technology Limited | Jinqiao Export Processing Zone (South) Shanghai, China | Manufacturer | 1 | March 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| LiteCure, LLC | Fort Worth, TX, United States | Manufacturer | 1 | March 29, 2013 | 0 | 0 | 0 | api.fda.gov |
| Toefx Inc. | Hamilton Ontario, Canada | Complaint file establishment, Manufacturer | 1 | November 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Candela Corporation | Marlborough, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gigaalaser Company Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Circuit (Shanghai) Ltd. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NPA de México S. de R.L. de C.V. | TIJUANA Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vydence Medical Industria e Comercio Ltda | CEAT - Sao Carlos/SP Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Phomed Technology Co., Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan DIMED LASER TECHNOLOGY CO., LTD. | Wuhan Hubei, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.