SPECTRA THERAPY SYSTEM A1000 LASER DEVICE— 510(k) K080689

Substantially Equivalent

Premier Dynamics, Inc.

FDA 510(k) clearance K080689 for SPECTRA THERAPY SYSTEM A1000 LASER DEVICE, Substantially Equivalent on 2008-07-09. Applicant: Premier Dynamics, Inc..

Clearance details

Applicant: Premier Dynamics, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2008-03-11
Decision date: 2008-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

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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.