510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082871Substantially Equivalent

Xact Lens Inserter System, Models 6Mm, 7Mm

Sis Ltd., Surgical Instrument Systems, Greenwood Village CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082871 is the FDA 510(k) clearance record for XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM, a class I device, cleared for Sis Ltd., Surgical Instrument Systems on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 3 510(k) clearances for Sis Ltd., Surgical Instrument Systems, from to . As of , FDA records show no recalls naming K082871.

Clearance record

Decision date
Received
(283 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
Sis Ltd., Surgical Instrument Systems 5401 Cottonwood Ct., Greenwood Village CO
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