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FDA 510(k)

SMARTLENS

K-Number: K002510 · 2000-10-18

ApplicantOdc Ophthalmic Development Co. AG
Decision Date2000-10-18
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SMARTLENS is the device name listed in this FDA 510(k) record. The listed applicant is Odc Ophthalmic Development Co. AG. It received FDA 510(k) clearance on 2000-10-18 under 510(k) number K002510. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTLENS?

SMARTLENS is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is Odc Ophthalmic Development Co. AG. The 510(k) number is K002510.

When did SMARTLENS receive FDA 510(k) clearance?

SMARTLENS received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002510.

Who is the listed applicant for SMARTLENS?

The FDA 510(k) record lists Odc Ophthalmic Development Co. AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTLENS?

The FDA product code for SMARTLENS is HKX.

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Related Devices (Code: HKX)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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