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510(k) K852054

CONTACT LENS LOUPE, INSPETION LOUPE by Ascon Medical Instruments, Ltd. — Product Code HLN

K852054 is an FDA 510(k) premarket notification submitted by Ascon Medical Instruments, Ltd. for the device "CONTACT LENS LOUPE, INSPETION LOUPE". The FDA issued a decision of Substantially Equivalent on September 5, 1985. The device falls under product code HLN (Gauge, Lens, Ophthalmic), a Class I device regulated under 21 CFR 886.1420. Ascon Medical Instruments, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1985
Date Received
May 9, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauge, Lens, Ophthalmic
Device Class
Class I
Regulation Number
886.1420
Review Panel
OP
Submission Type

Other clearances by Ascon Medical Instruments, Ltd.

  • K852055 — ASCON OPHTHALMIC SPONGE (September 4, 1985)
  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852057 — ASCON SURGICAL INSTRUMENTS (June 27, 1985)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)

Other clearances for product code HLN

  • K801466 — LEIGH MEASURING SCALE #7725 (July 28, 1980)

FDA data resources