# K120938: The PL-1064 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sheaumann Laser, Inc.
- Decided: Sep 24, 2012 after 186 days
- Product code: PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K936109 (1994). 34 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 1.

## Most influential descendants
- K133006: Neov Diode Laser Family (2014), 13 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K202991: Fotona XPulse Pro Laser Platform (2021), 3 descendants of its own
- K240179: Medical Diode Laser (Model: L2) (2024), 2 descendants of its own
- K230274: Medical Diode Laser (M2) (2023), 2 descendants of its own

## Indications for use
The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual and subungual warts and telangiectasia. The PL-1064 will also be indicated for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyt&s Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K120938
Methodology: https://510kreport.com/methodology