Xact Lens Inserter System, Models 6MM, 7MM

FDA 510(k) K082871 · Sis Ltd., Surgical Instrument Systems

Substantially Equivalent

510(k) numberK082871

Submission

Device name
Xact Lens Inserter System, Models 6MM, 7MM
Applicant
Sis Ltd., Surgical Instrument Systems
Greenwood Village, CO, US
Received
September 29, 2008
Decision date
July 9, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSS – Folders And Injectors, Intraocular Lens (Iol)
Device class
Class I (low risk)
Regulation
21 CFR 886.4300
Specialty
Ophthalmic

Other 510(k)s with product code MSS

510(k)DeviceApplicantDecision
K261174RxSight® Insertion DeviceMSS · Special Rxsight, Inc.06/10/2026SE
K252540ACCUJECT Injector Set 2.1-1P (LP604590)MSS · Traditional Medicel AG09/16/2025SE
K242389EyeGility™ Inserter for Preloaded enVista IOLsMSS · Traditional Bausch & Lomb, Incorporated10/10/2024SE
K231106Accuject Refra Injector AR2900MSS · Traditional Medicel AG09/19/2023SE
K231838RxSight® Insertion Device (63002)MSS · Traditional Rxsight, Inc.08/15/2023SE
K231466RxSight Insertion DeviceMSS · Special Rxsight, Inc.06/12/2023SE
K212039CLAREON MONARCH IV IOL Delivery SystemMSS · Traditional Alcon Laboratories, Inc.08/23/2021SE
K200057bioli lOL Delivery SystemMSS · Traditional Ast Products, Inc.06/04/2020SE
K192926RxSight Insertion DeviceMSS · Traditional Rxsight, Inc.01/17/2020SE
K192005Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special Bausch & Lomb, Inc.10/04/2019SE

More from Bausch & Lomb, Inc.

510(k)DeviceDecision
K051940CM 3910 Rotating Double Scheimpflug CameraMXK · Traditional 09/28/2005SE
K043150Amadeus II EpikeratomeHNO · Special 01/31/2005SE

Questions and answers

When was Xact Lens Inserter System, Models 6MM, 7MM cleared by the FDA?

Xact Lens Inserter System, Models 6MM, 7MM (K082871) received a 510(k) decision of Substantially Equivalent on July 9, 2009, 283 days after the submission was received.

What is the product code of K082871?

The FDA product code is MSS – Folders And Injectors, Intraocular Lens (Iol), a Class I (low risk) device regulated under 21 CFR 886.4300.