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FDA 510(k)

AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON

K-Number: K843345 · 1984-11-06

ApplicantMira, Inc.
Decision Date1984-11-06
Product Code
DecisionSubstantially Equivalent

Device Summary

AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON is the device name listed in this FDA 510(k) record. The listed applicant is Mira, Inc.. It received FDA 510(k) clearance on 1984-11-06 under 510(k) number K843345. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON?

AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON is a medical device that received FDA 510(k) clearance on 1984-11-06. The listed applicant is Mira, Inc.. The 510(k) number is K843345.

When did AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON receive FDA 510(k) clearance?

AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON received FDA 510(k) clearance on 1984-11-06, under 510(k) number K843345.

Who is the listed applicant for AGL400 ARGON LASER SYSTEM-KRL500 KRYPTON?

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

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Other records listing Mira, 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.

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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