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510(k) K894513

DIATHRON(R) DIATHERMY UNIT by Intl. Ophthalmic Industries Corp. — Product Code HJM

K894513 is an FDA 510(k) premarket notification submitted by Intl. Ophthalmic Industries Corp. for the device "DIATHRON(R) DIATHERMY UNIT". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Intl. Ophthalmic Industries Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1989
Date Received
July 19, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transilluminator, Ac-Powered
Device Class
Class II
Regulation Number
886.1945
Review Panel
OP
Submission Type

Other clearances by Intl. Ophthalmic Industries Corp.

  • K961658 — MEGATRON OPHTHALMIC SURGICAL SYSTEM (July 23, 1996)
  • K894511 — MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT (October 17, 1989)
  • K894512 — PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS (October 17, 1989)
  • K823088 — ASPITRON (April 6, 1983)
  • K791763 — (MICRO-KERATRON, MICRO DUCT TREPHINE) (November 5, 1979)

Other clearances for product code HJM

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K950529 — PEREGRINE DIFFUSION LIGHT PIPE (June 7, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K931072 — HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE (November 10, 1994)
  • K933445 — DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) (September 23, 1994)
  • K940393 — PEREGRINE WIDE ANGLE LIGHT PIPE (September 2, 1994)
  • K934269 — FIBEROPTIC ILLUMINATED INSTRUMENTS (May 17, 1994)
  • K913273 — DROLITE(TM) LIGHT SOURCE (December 4, 1991)
  • K893170 — VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (June 5, 1989)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources