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FDA 510(k)

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR

K-Number: K934706 · 1994-04-29

ApplicantCandela Laser Corp.
Decision Date1994-04-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR 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 1994-04-29 under 510(k) number K934706. 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 PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR?

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Candela Laser Corp.. The 510(k) number is K934706.

When did CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR receive FDA 510(k) clearance?

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR received FDA 510(k) clearance on 1994-04-29, under 510(k) number K934706.

Who is the listed applicant for CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR?

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 PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR?

The FDA product code for CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR 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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