FDA applicant

Aspen Laser Systems, LLC

Aurora, CO2 decisions2014–20150 recalls

FDA records 2 decisions for Aspen Laser Systems, LLC (Aurora, CO) from 2014 to 2015: 2 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and PDZ (Lasers For Temporary Increase Of Clear Nail In…). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Aspen Laser Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014high 1 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Aspen Laser Systems, LLC by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Aspen”

FDA records each applicant name separately; these may or may not be the same firm.

Aspen Laboratories, Inc. 55 Aspen Labs 6 Aspen Glove Sdn. Bhd. 4 Aspen Surgical Products, Inc. 2 Aspen Imaging Healthcare, Inc. 2 Aspen Medical, Ltd. 1

Aspen Laser Systems, LLC

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Aspen”