FDA applicant

Soma Blue, Inc.

Augusta, GA2 decisions1999–19990 recalls

FDA records 2 decisions for Soma Blue, Inc. (Augusta, GA) in 1999: 2 510(k) clearances. All are in product code LKY (Device, External Penile Rigidity). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Soma Blue, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Soma Blue, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Soma”

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

Soma Intl., Inc. 1 Soma Access Systems, LLC 1 Soma International, Ltd. 1

Soma Blue, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Soma”