# K150138: Aspen Laser Systems Therapy Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Aspen Laser Systems, LLC
- Decided: May 8, 2015 after 106 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (2025), 1 descendant of its own
- K253965: CureLight Medical Diode Laser Systems (CureLight F2-A15;  CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (2026), 0 descendants of its own

## Indications for use
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: * Matrixectomy, periungual and subungual warts, neuromas, and plantar warts. The VelasII is also indicated for use 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.).

Source page: https://510kreport.com/device/K150138
Methodology: https://510kreport.com/methodology