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FDA 510(k)

CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES

K-Number: K900858 · 1990-10-03

ApplicantCandela Laser Corp.
Decision Date1990-10-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES 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 1990-10-03 under 510(k) number K900858. 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 SPTL-1 LASER FOR TREATING BENIGN VASC. LES?

CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Candela Laser Corp.. The 510(k) number is K900858.

When did CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES receive FDA 510(k) clearance?

CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES received FDA 510(k) clearance on 1990-10-03, under 510(k) number K900858.

Who is the listed applicant for CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES?

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 SPTL-1 LASER FOR TREATING BENIGN VASC. LES?

The FDA product code for CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES is GEX. This falls under the Gastroenterology category.

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Other records listing Candela Laser Corp. as applicant

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.

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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