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FDA 510(k)

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

K-Number: K240169 · 2024-07-26

Decision Date2024-07-26
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) is the device name listed in this FDA 510(k) record. The listed applicant is Bausch and Lomb, Incorporated. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K240169. 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 (BL11145, BL14455, BL15455)?

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Bausch and Lomb, Incorporated. The 510(k) number is K240169.

When did Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) receive FDA 510(k) clearance?

Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) received FDA 510(k) clearance on 2024-07-26, under 510(k) number K240169.

Who is the listed applicant for Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)?

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

What is the FDA product code for Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)?

The FDA product code for Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) is HQC.

Other records listing Bausch and Lomb, Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 7 devices →

Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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