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FDA 510(k)

O-LAS OPHTHALMIC PHOTODISRUPTOR

K-Number: K001511 · 2000-07-19

ApplicantA.R.C. Laser AG
Decision Date2000-07-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

O-LAS OPHTHALMIC PHOTODISRUPTOR is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C. Laser AG. It received FDA 510(k) clearance on 2000-07-19 under 510(k) number K001511. 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 O-LAS OPHTHALMIC PHOTODISRUPTOR?

O-LAS OPHTHALMIC PHOTODISRUPTOR is a medical device that received FDA 510(k) clearance on 2000-07-19. The listed applicant is A.R.C. Laser AG. The 510(k) number is K001511.

When did O-LAS OPHTHALMIC PHOTODISRUPTOR receive FDA 510(k) clearance?

O-LAS OPHTHALMIC PHOTODISRUPTOR received FDA 510(k) clearance on 2000-07-19, under 510(k) number K001511.

Who is the listed applicant for O-LAS OPHTHALMIC PHOTODISRUPTOR?

The FDA 510(k) record lists A.R.C. Laser AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for O-LAS OPHTHALMIC PHOTODISRUPTOR?

The FDA product code for O-LAS OPHTHALMIC PHOTODISRUPTOR is GEX. This falls under the Gastroenterology category.

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Other records listing A.R.C. Laser AG 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.

K003512LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK IIK002986A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5

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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