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FDA 510(k)

MODEL 900S INTRAOCULAR PROBE

K-Number: K812219 · 1981-11-16

ApplicantLumenis, Inc.
Decision Date1981-11-16
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 900S INTRAOCULAR PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812219. 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 MODEL 900S INTRAOCULAR PROBE?

MODEL 900S INTRAOCULAR PROBE is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Lumenis, Inc.. The 510(k) number is K812219.

When did MODEL 900S INTRAOCULAR PROBE receive FDA 510(k) clearance?

MODEL 900S INTRAOCULAR PROBE received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812219.

Who is the listed applicant for MODEL 900S INTRAOCULAR PROBE?

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

What is the FDA product code for MODEL 900S INTRAOCULAR PROBE?

The FDA product code for MODEL 900S INTRAOCULAR PROBE is HQF.

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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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