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FDA 510(k)

LPI ML210 HOLMIUM SURGICAL LASER

K-Number: K924537 · 1993-04-07

ApplicantLaser Photonics, Inc.
Decision Date1993-04-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LPI ML210 HOLMIUM SURGICAL LASER 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 1993-04-07 under 510(k) number K924537. 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 ML210 HOLMIUM SURGICAL LASER?

LPI ML210 HOLMIUM SURGICAL LASER is a medical device that received FDA 510(k) clearance on 1993-04-07. The listed applicant is Laser Photonics, Inc.. The 510(k) number is K924537.

When did LPI ML210 HOLMIUM SURGICAL LASER receive FDA 510(k) clearance?

LPI ML210 HOLMIUM SURGICAL LASER received FDA 510(k) clearance on 1993-04-07, under 510(k) number K924537.

Who is the listed applicant for LPI ML210 HOLMIUM SURGICAL LASER?

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 ML210 HOLMIUM SURGICAL LASER?

The FDA product code for LPI ML210 HOLMIUM SURGICAL LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Photonics, Inc. 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.

K934501LASER PHOTONICS ML755 DERMABLASERK933140RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEMK920334LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.K915631LPI ML 100/532 AND ML 532 SURGICAL LASERK914827LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATIONK904841LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED

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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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