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FDA 510(k)

LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED

K-Number: K904841 · 1991-04-19

ApplicantLaser Photonics, Inc.
Decision Date1991-04-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Laser Photonics, Inc.. It received FDA 510(k) clearance on 1991-04-19 under 510(k) number K904841. 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 LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED?

LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED is a medical device that received FDA 510(k) clearance on 1991-04-19. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K904841.

When did LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED receive FDA 510(k) clearance?

LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED received FDA 510(k) clearance on 1991-04-19, under 510(k) number K904841.

Who is the listed applicant for LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED?

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

What is the FDA product code for LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED?

The FDA product code for LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Photonics, Inc. 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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