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FDA 510(k)

DERMASCAN LASER SURGICAL HANDPIECE

K-Number: K860083 · 1986-08-07

ApplicantMedical Laser Research & Development Corp.
Decision Date1986-08-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMASCAN LASER SURGICAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser Research & Development Corp.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K860083. 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 DERMASCAN LASER SURGICAL HANDPIECE?

DERMASCAN LASER SURGICAL HANDPIECE is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Medical Laser Research & Development Corp.. The 510(k) number is K860083.

When did DERMASCAN LASER SURGICAL HANDPIECE receive FDA 510(k) clearance?

DERMASCAN LASER SURGICAL HANDPIECE received FDA 510(k) clearance on 1986-08-07, under 510(k) number K860083.

Who is the listed applicant for DERMASCAN LASER SURGICAL HANDPIECE?

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

What is the FDA product code for DERMASCAN LASER SURGICAL HANDPIECE?

The FDA product code for DERMASCAN LASER SURGICAL HANDPIECE is GEX. This falls under the Gastroenterology category.

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Official Source

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

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