510(k) Report

FDA applicant

Lerner Medical Devices, Inc.

Los Angeles, CA3 decisions2004–20090 recalls

FDA records 3 decisions for Lerner Medical Devices, Inc. (Los Angeles, CA) from 2004 to 2009: 3 510(k) clearances. All are in product code FTC (Light, Ultraviolet, Dermatological). Its devices cite 15 predicates, 2 of them its own earlier devices. 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, general and plastic surgery panel, where it files most

How often FDA has decided Lerner Medical Devices, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lerner Medical Devices, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lerner Medical Devices, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Lerner”

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