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FDA 510(k)

MICROLASE 8 0 0 (OPHTHALMIC LASER)

K-Number: K890086 · 1989-03-15

ApplicantKeeler Instruments, Inc.
Decision Date1989-03-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MICROLASE 8 0 0 (OPHTHALMIC LASER) is the device name listed in this FDA 510(k) record. The listed applicant is Keeler Instruments, Inc.. It received FDA 510(k) clearance on 1989-03-15 under 510(k) number K890086. 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 MICROLASE 8 0 0 (OPHTHALMIC LASER)?

MICROLASE 8 0 0 (OPHTHALMIC LASER) is a medical device that received FDA 510(k) clearance on 1989-03-15. The listed applicant is Keeler Instruments, Inc.. The 510(k) number is K890086.

When did MICROLASE 8 0 0 (OPHTHALMIC LASER) receive FDA 510(k) clearance?

MICROLASE 8 0 0 (OPHTHALMIC LASER) received FDA 510(k) clearance on 1989-03-15, under 510(k) number K890086.

Who is the listed applicant for MICROLASE 8 0 0 (OPHTHALMIC LASER)?

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

What is the FDA product code for MICROLASE 8 0 0 (OPHTHALMIC LASER)?

The FDA product code for MICROLASE 8 0 0 (OPHTHALMIC LASER) is HQF.

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Other records listing Keeler Instruments, 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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