DIOWAVE LOW LEVEL COLD LASER SYSTEM— 510(k) K121363

Substantially Equivalent

Technological Medical Advancments, Inc. (Tma)

FDA 510(k) clearance K121363 for DIOWAVE LOW LEVEL COLD LASER SYSTEM, Substantially Equivalent on 2012-11-23. Applicant: Technological Medical Advancments, Inc. (Tma).

Clearance details

Applicant: Technological Medical Advancments, Inc. (Tma)
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2012-05-07
Decision date: 2012-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Palm Beach, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.