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Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

by Bausch & Lomb Incorporated

510(k) K252052

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK252052 Date25 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQC
FDA applicant
Bausch and Lomb, Incorporated
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Stellaris Elite vision enhancement system is a unit used for phacofragmentation, a surgical procedure involving the emulsification and removal of the crystalline lens during cataract surgery. It is classified as a Class II medical device under FDA regulation 886.4670 and is designated for ophthalmic use.

The system received FDA 510(k) clearance via traditional pathway (K252052) and was found substantially equivalent to a predicate device. It is manufactured by Bausch & Lomb Incorporated and is authorized for distribution in the United States.

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