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FDA 510(k)

CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE

K-Number: K954934 · 1996-02-02

ApplicantCandela Laser Corp.
Decision Date1996-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE 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 1996-02-02 under 510(k) number K954934. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE?

CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE is a medical device that received FDA 510(k) clearance on 1996-02-02. The listed applicant is Candela Laser Corp.. The 510(k) number is K954934.

When did CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE receive FDA 510(k) clearance?

CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE received FDA 510(k) clearance on 1996-02-02, under 510(k) number K954934.

Who is the listed applicant for CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE?

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 CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE?

The FDA product code for CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE is GEX. This falls under the Gastroenterology category.

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Other records listing Candela Laser Corp. as applicant

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Related Devices (Code: GEX)

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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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