510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192005Substantially Equivalent

Bausch + Lomb PreVue Inserter for enVista Preloaded

Bausch & Lomb Incorporated, St. Louis MO / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192005 is the FDA 510(k) clearance record for Bausch + Lomb PreVue Inserter for enVista Preloaded, a class I device, cleared for Bausch & Lomb, Inc. on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K192005.

Clearance record

Decision date
Received
(67 days to decision)
Product code
MSS Folders And Injectors, Intraocular Lens (Iol)
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Bausch & Lomb, Inc. 3365 Tree Ct. Industrial Blvd., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSS

Trailing 12 months
1 clearance under product code MSS in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260