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510(k) K974243

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

K974243 is an FDA 510(k) premarket notification submitted by Insight Technologies Instruments, LLC for the device "KERATOME SYSTEM". The FDA issued a decision of Substantially Equivalent on January 20, 1998. 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
January 20, 1998
Date Received
November 12, 1997
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

  • K984537 — KERATOME SYSTEM, MODEL K3000 (May 14, 1999)

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)
  • K984537 — KERATOME SYSTEM, MODEL K3000 (May 14, 1999)
  • K981741 — CARRIAZO BARRAQUER MICROKERATOME (July 24, 1998)
  • K902857 — VISI-DRAPE OPHTHALMIC DRAPES (July 31, 1990)

FDA data resources