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510(k) K990064

DI-RHEX OPHTHALMIC DIATHERMY SYSTEM by Ophthalmic Technologies, Inc. — Product Code HQR

K990064 is an FDA 510(k) premarket notification submitted by Ophthalmic Technologies, Inc. for the device "DI-RHEX OPHTHALMIC DIATHERMY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 4, 1999. The device falls under product code HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Ophthalmic Technologies, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1999
Date Received
January 8, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type

Other clearances by Ophthalmic Technologies, Inc.

  • K042885 — OCT-OPTHALMOSCOPE (January 21, 2005)
  • K031391 — HF MODULE WITH TRANSDUCERS (June 20, 2003)
  • K030770 — OTI SCAN WITH TRANSDUCERS (March 27, 2003)
  • K024114 — A-SCAN 100 (January 10, 2003)
  • K974522 — 3D I-SCAN (February 25, 1998)
  • K971679 — I-SCOPE OPHTHALMIC ENDOSCOPE (June 25, 1997)
  • K960622 — I-SCAN (May 13, 1996)
  • K954263 — XE-LITE (October 18, 1995)

Other clearances for product code HQR

  • K050308 — THERMAL CAUTERY PROBE (February 25, 2005)
  • K980522 — REFRACTEC MCS-100 (July 22, 1998)
  • K972749 — PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) (March 13, 1998)
  • K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR C (March 4, 1996)
  • K955158 — SURGITRON (February 9, 1996)
  • K952569 — GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR (January 5, 1996)
  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)

FDA data resources