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510(k) K780931

SOFT LENS INSERTER by Soft-Sert — Product Code KYE

K780931 is an FDA 510(k) premarket notification submitted by Soft-Sert for the device "SOFT LENS INSERTER". The FDA issued a decision of Substantially Equivalent on June 28, 1978. The device falls under product code KYE (Inserter/Remover Contact Lens), a Class I device regulated under 21 CFR 886.5420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1978
Date Received
June 6, 1978
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 for product code KYE

  • K872567 — SOFT CONTACT LENS REMOVER (August 10, 1987)
  • 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)
  • 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)
  • K780664 — SOFT LENS REMOVER/INSERTER/MANIPULATOR (May 17, 1978)

FDA data resources