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510(k) K850270

CORNEAL LIGHT SHIELD by Mentor O & O, Inc. — Product Code HRM

K850270 is an FDA 510(k) premarket notification submitted by Mentor O & O, Inc. for the device "CORNEAL LIGHT SHIELD". The FDA issued a decision of Substantially Equivalent on May 31, 1985. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Mentor O & O, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1985
Date Received
January 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
878.4700
Review Panel
SU
Submission Type

Other clearances by Mentor O & O, Inc.

  • K955245 — MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM (February 12, 1996)
  • K934320 — MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION A (February 16, 1994)
  • K912904 — MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM (June 11, 1992)
  • K915340 — MENTOR HORIZON LOW VISION MAGNIFIER (March 30, 1992)
  • K910637 — MENTOR(R) SUR-E-TROL(R) (May 13, 1991)
  • K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 (May 2, 1991)
  • K903878 — MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT (November 5, 1990)
  • K895010 — MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE (September 11, 1989)
  • K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II (May 4, 1989)
  • K890595 — MENTOR ANTERIOR SEGMENT VITRECTOR (April 17, 1989)

Other clearances for product code HRM

  • K932720 — HM-0970 (September 7, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • K920641 — ALCON OPERATING MICROSCOPES (October 9, 1992)
  • K914956 — KEELER KONAN SPECULAR MICROSCOPE SP5500 (February 3, 1992)
  • K891584 — S 22 INSTRUMENT STAND (June 8, 1989)
  • K891001 — MICROSCOPE KNOB COVER, STERILE, DISPOSABLE (April 11, 1989)
  • K854440 — MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50 (December 16, 1985)
  • K853855 — XTAL X-150 OPERATING MICROSCOPE (October 15, 1985)
  • K852586 — CROMIC SURGICAL MICROSCOPE MODEL MC-1 (July 30, 1985)
  • K852150 — CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500 (June 3, 1985)

FDA data resources