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510(k) K984537

KERATOME SYSTEM, MODEL K3000 by Insight Technologies Instruments, LLC — Product Code HMY

K984537 is an FDA 510(k) premarket notification submitted by Insight Technologies Instruments, LLC for the device "KERATOME SYSTEM, MODEL K3000". The FDA issued a decision of Substantially Equivalent on May 14, 1999. The device falls under product code HMY (Keratome, Battery-Powered), a Class I device regulated under 21 CFR 886.4370. Insight Technologies Instruments, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1999
Date Received
December 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Battery-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Insight Technologies Instruments, LLC

  • K974243 — KERATOME SYSTEM (January 20, 1998)

Other clearances for product code HMY

  • K040297 — ONEUSE- PLUS MICROKERATOME (March 31, 2004)
  • K023092 — BD K-4000 MICROKERATOME SYSTEM (October 18, 2002)
  • K022637 — BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME (October 16, 2002)
  • K022560 — M2 SINGLE USE MICROKERTOME (September 27, 2002)
  • K003594 — CARRIAZO BARRAQUER SINGLE USE MICROKERATOME (March 9, 2001)
  • K002191 — CARRIAZO BARRAQUER II MICROKERATOME (October 12, 2000)
  • K992687 — MILLENIUM MICROKERATOME, MODEL IMD-001 (September 24, 1999)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)
  • K974243 — KERATOME SYSTEM (January 20, 1998)
  • K902857 — VISI-DRAPE OPHTHALMIC DRAPES (July 31, 1990)

FDA data resources