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FDA 510(k)

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.

K-Number: K920062 · 1992-06-05

ApplicantCandela Laser Corp.
Decision Date1992-06-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. 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 1992-06-05 under 510(k) number K920062. 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 LAS.?

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. is a medical device that received FDA 510(k) clearance on 1992-06-05. The listed applicant is Candela Laser Corp.. The 510(k) number is K920062.

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

CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. received FDA 510(k) clearance on 1992-06-05, under 510(k) number K920062.

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

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 LAS.?

The FDA product code for CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. 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)

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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