510(k) Report

FDA applicant

Tiger Aesthetics Medical, LLC

Franklin2 decisions2006–20120 recalls

FDA records 2 decisions for Tiger Aesthetics Medical, LLC (Franklin) from 2006 to 2012: 2 original PMA approvals. Most are in product codes FTR (Prosthesis, Breast, Noninflatable, Internal…) and LMH (Implant, Dermal, For Aesthetic Use). 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 Tiger Aesthetics Medical, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Tiger”

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