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510(k) K871130

CONTACT LENS TWEEZERS by S. M. C. Medi-Tech Corp. — Product Code KYE

K871130 is an FDA 510(k) premarket notification submitted by S. M. C. Medi-Tech Corp. for the device "CONTACT LENS TWEEZERS". The FDA issued a decision of Substantially Equivalent on May 12, 1987. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420. S. M. C. Medi-Tech Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1987
Date Received
March 20, 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 S. M. C. Medi-Tech Corp.

  • K863846 — CONTAC CASE (April 6, 1987)

Other clearances for product code KYE

  • K872567 — SOFT CONTACT LENS REMOVER (August 10, 1987)
  • K872591 — HARD CONTACT LENS REMOVER. ITEM #289 (August 4, 1987)
  • K870072 — SUMMIT OPTICS CONTACT LENS REMOVER (February 12, 1987)
  • K850984 — MARLIN SOFT LENS HANDLER (September 10, 1985)
  • K850983 — MARLIN SOFT LENS TWEEZER (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)
  • K780664 — SOFT LENS REMOVER/INSERTER/MANIPULATOR (May 17, 1978)

FDA data resources