DeviceClearance

CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER— 510(k) K972767

Substantially Equivalent

Candela Corp.

FDA 510(k) clearance K972767 for CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER, Substantially Equivalent on 1997-12-04. Applicant: Candela Corp.. Device class: 2.

Clearance details

Applicant
Candela Corp.
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
Wayland, MA, US
Download summary PDFView on FDA.gov ↗

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More clearances from Candela Corp.

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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 K972767

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 K972767.

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