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510(k) K913273

DROLITE(TM) LIGHT SOURCE by Vision Medical, Inc. — Product Code HJM

K913273 is an FDA 510(k) premarket notification submitted by Vision Medical, Inc. for the device "DROLITE(TM) LIGHT SOURCE". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code HJM (Transilluminator, Ac-Powered), a Class II device regulated under 21 CFR 886.1945. Vision Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
July 23, 1991
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 Vision Medical, Inc.

  • K913837 — MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM (November 5, 1991)

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)
  • K894513 — DIATHRON(R) DIATHERMY UNIT (October 31, 1989)
  • K893170 — VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) (June 5, 1989)
  • K812949 — RMI TRANSILLUMINATOR, MODEL 292 (December 2, 1981)

FDA data resources