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510(k) K912522

OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER by Summit Technology, Inc. — Product Code EQH

K912522 is an FDA 510(k) premarket notification submitted by Summit Technology, Inc. for the device "OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER". The FDA issued a decision of Substantially Equivalent on July 25, 1991. The device falls under product code EQH (Source, Carrier, Fiberoptic Light), a Class I device regulated under 21 CFR 874.4350. Summit Technology, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1991
Date Received
May 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
Submission Type

Other clearances by Summit Technology, Inc.

  • K980675 — SUMMIT KRUMEICH-BARRAQUER MICROKERATOME (December 22, 1998)
  • K926470 — LASER AND EMPHASIS SCLEROSTOMY TIP (July 22, 1993)
  • K915651 — OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM (June 15, 1992)
  • K904470 — SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (December 24, 1990)

Other clearances for product code EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)

FDA data resources