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FDA 510(k)

Stellaris Elite vision enhancement system

K-Number: K170052 · 2017-04-19

ApplicantBausch+Lomb
Decision Date2017-04-19
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Stellaris Elite vision enhancement system is a medical device manufactured by Bausch+Lomb. It received FDA 510(k) clearance on 2017-04-19 under approval number K170052. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stellaris Elite vision enhancement system?

Stellaris Elite vision enhancement system is a medical device that received FDA 510(k) clearance on 2017-04-19. It is manufactured by Bausch+Lomb. The 510(k) number is K170052.

When was Stellaris Elite vision enhancement system approved by the FDA?

Stellaris Elite vision enhancement system received FDA 510(k) clearance on 2017-04-19, under approval number K170052.

What company makes Stellaris Elite vision enhancement system?

Stellaris Elite vision enhancement system is manufactured by Bausch+Lomb.

What is the FDA product code for Stellaris Elite vision enhancement system?

The FDA product code for Stellaris Elite vision enhancement system is HQC.

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Other Devices by Bausch+Lomb

K162342Stellaris Elite Vision Enhancement System

Related Devices (Code: HQC)

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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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