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FDA 510(k)

OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE

K-Number: K982031 · 1998-09-08

ApplicantIridex Corp
Decision Date1998-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corp. It received FDA 510(k) clearance on 1998-09-08 under 510(k) number K982031. 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 OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE?

OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE is a medical device that received FDA 510(k) clearance on 1998-09-08. The listed applicant is Iridex Corp. The 510(k) number is K982031.

When did OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE receive FDA 510(k) clearance?

OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE received FDA 510(k) clearance on 1998-09-08, under 510(k) number K982031.

Who is the listed applicant for OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE?

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

What is the FDA product code for OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE?

The FDA product code for OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Iridex 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.

K121475TXCELL SCANNING LASER DELIVERY SYSTEMK071687FAMILI OF IRIDEX IQ LASER SYSTEMSK062074IRIDEX WIRELESS FOOTSWITCHK062369IRIDEX OCULIGHT TXK060905IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1K050562OCULIGHT GL/GLX

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Related Devices (Code: GEX)

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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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