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510(k) K981665

SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE by Bio-Medical Sciences, Inc. — Product Code MMQ

K981665 is an FDA 510(k) premarket notification submitted by Bio-Medical Sciences, Inc. for the device "SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE". The FDA issued a decision of Substantially Equivalent on December 7, 1998. The device falls under product code MMQ (Topographer, Corneal, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Bio-Medical Sciences, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1998
Date Received
May 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Topographer, Corneal, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

Other clearances by Bio-Medical Sciences, Inc.

  • K813202 — THERMALOG S STEAM STERILIZATION INTEGRA (December 31, 1981)
  • K772358 — ETHYLENE OXIDE STERILI. INDICATOR (January 30, 1978)

Other clearances for product code MMQ

  • K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (May 20, 1997)
  • K964891 — ORBSHOT KERATOMETER (March 26, 1997)
  • K963762 — CORNEAL TOPOGRAPHER 200 (December 23, 1996)
  • K950077 — INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (June 14, 1995)

FDA data resources