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FDA 510(k)

OPHALMIC LASER PHOTOCOAGULATOR

K-Number: K854288 · 1985-11-12

ApplicantMira, Inc.
Decision Date1985-11-12
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHALMIC LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1985-11-12 under 510(k) number K854288. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHALMIC LASER PHOTOCOAGULATOR?

OPHALMIC LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Mira, Inc.. The 510(k) number is K854288.

When did OPHALMIC LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

OPHALMIC LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854288.

Who is the listed applicant for OPHALMIC LASER PHOTOCOAGULATOR?

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

What is the FDA product code for OPHALMIC LASER PHOTOCOAGULATOR?

The FDA product code for OPHALMIC LASER PHOTOCOAGULATOR is HQF.

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Other records listing Mira, Inc. as applicant

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K951728SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPEK950806SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTSK941495RETURN PATH DIATHERMY HANDLEK933527MODIFICATION OF ANTERIOR SEGMENT ELECTRODESK923629OPHTHALMIC TRICHIASIS PROBEK894248CONVERTER SYSTEM

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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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