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FDA 510(k)

CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)

K-Number: K950351 · 1995-03-24

ApplicantIon Laser Technology
Decision Date1995-03-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Ion Laser Technology. It received FDA 510(k) clearance on 1995-03-24 under 510(k) number K950351. 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 CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)?

CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Ion Laser Technology. The 510(k) number is K950351.

When did CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) receive FDA 510(k) clearance?

CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) received FDA 510(k) clearance on 1995-03-24, under 510(k) number K950351.

Who is the listed applicant for CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)?

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

What is the FDA product code for CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)?

The FDA product code for CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION) is GEX. This falls under the Gastroenterology category.

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Other records listing Ion Laser Technology 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.

K974369APOLLO 9500K964524ILT ARGON HPK953898ACL-5500 PRECISION CURING UNIT (PCU)K954460ILT SURGICAL LASERK944317GENESIS 2000K944206GENESIS 2000

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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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