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FDA 510(k)

CANDELA MODEL SPT-1, PULSED DYE LASER

K-Number: K861179 · 1986-11-20

ApplicantCandela Corp.
Decision Date1986-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA MODEL SPT-1, PULSED DYE LASER is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corp.. It received FDA 510(k) clearance on 1986-11-20 under 510(k) number K861179. 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 MODEL SPT-1, PULSED DYE LASER?

CANDELA MODEL SPT-1, PULSED DYE LASER is a medical device that received FDA 510(k) clearance on 1986-11-20. The listed applicant is Candela Corp.. The 510(k) number is K861179.

When did CANDELA MODEL SPT-1, PULSED DYE LASER receive FDA 510(k) clearance?

CANDELA MODEL SPT-1, PULSED DYE LASER received FDA 510(k) clearance on 1986-11-20, under 510(k) number K861179.

Who is the listed applicant for CANDELA MODEL SPT-1, PULSED DYE LASER?

The FDA 510(k) record lists Candela Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANDELA MODEL SPT-1, PULSED DYE LASER?

The FDA product code for CANDELA MODEL SPT-1, PULSED DYE LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Candela Corp. as applicant

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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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