DeviceClearance

LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS— 510(k) K082721

Substantially Equivalent

Photo Medex, Inc.

FDA 510(k) clearance K082721 for LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS, Substantially Equivalent on 2008-10-28. Applicant: Photo Medex, Inc.. Device class: 2.

Clearance details

Applicant
Photo Medex, Inc.
Product code
Code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Montgomeryville, PA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Photo Medex, Inc.

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

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

Recalls naming K082721

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082721.

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