FDA 510(k)

Bausch + Lomb Boston Scleral Lens Case

K-Number: K173365 · 2017-11-17

Decision Date2017-11-17

Product CodeLRX

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Bausch + Lomb Boston Scleral Lens Case is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Incorporated. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K173365. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bausch + Lomb Boston Scleral Lens Case?

Bausch + Lomb Boston Scleral Lens Case is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K173365.

When did Bausch + Lomb Boston Scleral Lens Case receive FDA 510(k) clearance?

Bausch + Lomb Boston Scleral Lens Case received FDA 510(k) clearance on 2017-11-17, under 510(k) number K173365.

Who is the listed applicant for Bausch + Lomb Boston Scleral Lens Case?

The FDA 510(k) record lists Bausch & Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bausch + Lomb Boston Scleral Lens Case?

The FDA product code for Bausch + Lomb Boston Scleral Lens Case is LRX.

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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.