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510(k) K872567

SOFT CONTACT LENS REMOVER by Magnivision, Inc. — Product Code KYE

K872567 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "SOFT CONTACT LENS REMOVER". The FDA issued a decision of Substantially Equivalent on August 10, 1987. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. Magnivision, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1987
Date Received
June 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Inserter/Remover Contact Lens
Device Class
Class I
Regulation Number
886.5420
Review Panel
OP
Submission Type

Other clearances by Magnivision, Inc.

  • K900778 — ITEM #272 MAGNIF-EYES CONTACT LENS CASE (March 30, 1990)
  • K900777 — ITEM #273 CONTACT LENS CASES (March 30, 1990)
  • K897084 — CONFEES(R)+ CONTACT LENS HOLDER (February 28, 1990)
  • K897085 — COMFEES(R) + CON-PAK(TM) LENS CASE (February 28, 1990)
  • K882384 — DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 (June 23, 1989)
  • K890533 — ITEM #352/#CS352* CONTACT LENS CASES (June 23, 1989)
  • K872591 — HARD CONTACT LENS REMOVER. ITEM #289 (August 4, 1987)

Other clearances for product code KYE

  • K872591 — HARD CONTACT LENS REMOVER. ITEM #289 (August 4, 1987)
  • K871130 — CONTACT LENS TWEEZERS (May 12, 1987)
  • K870072 — SUMMIT OPTICS CONTACT LENS REMOVER (February 12, 1987)
  • K850983 — MARLIN SOFT LENS TWEEZER (September 10, 1985)
  • K850984 — MARLIN SOFT LENS HANDLER (September 10, 1985)
  • K830738 — LENSERT CONTACT LENS CLEANING & INSERT (June 10, 1983)
  • K830496 — DMV ANGLER (March 9, 1983)
  • K782140 — REMOVER, SOFT-SERT CONTACT LENS (February 12, 1979)
  • K780931 — SOFT LENS INSERTER (June 28, 1978)
  • K780663 — CONTACT LENS REMOVER AND INSERTER (May 17, 1978)

FDA data resources