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FDA 510(k)

CANDEKA DUKATIR SETS

K-Number: K950635 · 1995-03-01

ApplicantCandela Laser Corp.
Decision Date1995-03-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CANDEKA DUKATIR SETS is the device name listed in this FDA 510(k) record. The listed applicant is Candela Laser Corp.. It received FDA 510(k) clearance on 1995-03-01 under 510(k) number K950635. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDEKA DUKATIR SETS?

CANDEKA DUKATIR SETS is a medical device that received FDA 510(k) clearance on 1995-03-01. The listed applicant is Candela Laser Corp.. The 510(k) number is K950635.

When did CANDEKA DUKATIR SETS receive FDA 510(k) clearance?

CANDEKA DUKATIR SETS received FDA 510(k) clearance on 1995-03-01, under 510(k) number K950635.

Who is the listed applicant for CANDEKA DUKATIR SETS?

The FDA 510(k) record lists Candela Laser Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANDEKA DUKATIR SETS?

The FDA product code for CANDEKA DUKATIR SETS is DQY.

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Other records listing Candela Laser Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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