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FDA 510(k)

INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM

K-Number: K030181 · 2003-04-17

ApplicantInternational Biophysics Corp.
Decision Date2003-04-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is International Biophysics Corp.. It received FDA 510(k) clearance on 2003-04-17 under 510(k) number K030181. 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 INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM?

INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-17. The listed applicant is International Biophysics Corp.. The 510(k) number is K030181.

When did INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM receive FDA 510(k) clearance?

INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM received FDA 510(k) clearance on 2003-04-17, under 510(k) number K030181.

Who is the listed applicant for INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM?

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

What is the FDA product code for INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM?

The FDA product code for INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM is GEX. This falls under the Gastroenterology category.

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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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