DERMATOLOGIC TREATMENT SYSTEM (DTS) G2— 510(k) K082819

Substantially Equivalent

Miramar Labs, Inc.

FDA 510(k) clearance K082819 for DERMATOLOGIC TREATMENT SYSTEM (DTS) G2, Substantially Equivalent on 2009-03-20. Applicant: Miramar Labs, Inc..

Clearance details

Applicant: Miramar Labs, Inc.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2008-09-25
Decision date: 2009-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

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Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.