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FDA 510(k)

OPTI-BRUSH

K-Number: K864157 · 1986-11-13

ApplicantWillmar Contact Lens Clinic
Decision Date1986-11-13
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTI-BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Willmar Contact Lens Clinic. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K864157. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-BRUSH?

OPTI-BRUSH is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Willmar Contact Lens Clinic. The 510(k) number is K864157.

When did OPTI-BRUSH receive FDA 510(k) clearance?

OPTI-BRUSH received FDA 510(k) clearance on 1986-11-13, under 510(k) number K864157.

Who is the listed applicant for OPTI-BRUSH?

The FDA 510(k) record lists Willmar Contact Lens Clinic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTI-BRUSH?

The FDA product code for OPTI-BRUSH is LPN.

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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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