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FDA 510(k)

CANDELA ELLIPTICAL SPOT HANDPIECE

K-Number: K945587 · 1994-12-08

ApplicantCandela Laser Corp.
Decision Date1994-12-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA ELLIPTICAL SPOT HANDPIECE 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 1994-12-08 under 510(k) number K945587. 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 ELLIPTICAL SPOT HANDPIECE?

CANDELA ELLIPTICAL SPOT HANDPIECE is a medical device that received FDA 510(k) clearance on 1994-12-08. The listed applicant is Candela Laser Corp.. The 510(k) number is K945587.

When did CANDELA ELLIPTICAL SPOT HANDPIECE receive FDA 510(k) clearance?

CANDELA ELLIPTICAL SPOT HANDPIECE received FDA 510(k) clearance on 1994-12-08, under 510(k) number K945587.

Who is the listed applicant for CANDELA ELLIPTICAL SPOT HANDPIECE?

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 ELLIPTICAL SPOT HANDPIECE?

The FDA product code for CANDELA ELLIPTICAL SPOT HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Candela Laser Corp. as applicant

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K951033ANDELA DYNAMIC COOLING DEVICEK955662CANDELA Q-SWITCHED ALEXANDRITE LASERSK955011CANDELA HCS 2000 URETHERAL WARMER CATHETERK954872CANDELA CRYO-PROBE HOLDERK954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASEK953412CANDELA MODEL PLTL-1 LASER SYSTEM

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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