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510(k) K861990

SOFT LENS FOLDER by Staar Surgical Co. — Product Code KYB

K861990 is an FDA 510(k) premarket notification submitted by Staar Surgical Co. for the device "SOFT LENS FOLDER". The FDA issued a decision of Substantially Equivalent on June 17, 1986. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Staar Surgical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1986
Date Received
May 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

Other clearances by Staar Surgical Co.

  • K172375 — MicroSTAAR Injector System Cartridges (September 6, 2017)
  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K090161 — EPIPHANY INJECTION SYSTEM (June 9, 2009)
  • K073586 — MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K073591 — MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM (March 13, 2008)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K020734 — SURGE-FREE ASPIRATION ADAPTER (May 16, 2002)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)
  • K980696 — FOAM TIP INJECTOR (September 11, 1998)
  • K954600 — MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION) (December 21, 1995)

Other clearances for product code KYB

  • K152357 — MicroSTAAR Injector System Cartridges (October 30, 2015)
  • K081382 — DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 (October 23, 2008)
  • K072985 — DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2 (June 20, 2008)
  • K070669 — IOL INJECTOR SET (November 1, 2007)
  • K063155 — MONARCH III IOL DELIVERY SYSTEM (March 27, 2007)
  • K063694 — AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 (March 7, 2007)
  • K032412 — RE-USEABLE MICROSTAAR INJECTOR, MSI-S (June 10, 2004)
  • K022723 — MASTEL 1 FOLDER IMPLANTATION SYSTEM (December 26, 2002)
  • K001157 — MONARCH II IOL DELIVERY SYSTEM (June 27, 2000)
  • K983129 — DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) (December 4, 1998)

FDA data resources