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510(k) K920641

ALCON OPERATING MICROSCOPES by Alcon Laboratories — Product Code HRM

K920641 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "ALCON OPERATING MICROSCOPES". The FDA issued a decision of Substantially Equivalent on October 9, 1992. The device falls under product code HRM (Microscope, Operating & Accessories, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 878.4700. Alcon Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1992
Date Received
February 12, 1992
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 Alcon Laboratories

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  • K252682 — LenSx Laser System (8065000944) (September 24, 2025)
  • K243896 — LenSx Laser System (8065998162) (April 28, 2025)
  • K243909 — Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astig (January 13, 2025)
  • K242184 — Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (806 (December 4, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K233856 — Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL3 (December 29, 2023)
  • K232921 — DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTA (November 16, 2023)
  • K230785 — Precision1, Precision1 for Astigmatism (April 20, 2023)

Other clearances for product code HRM

  • K932720 — HM-0970 (September 7, 1993)
  • K930439 — MARCO SURGISCOPE OPERATION MICROSCOPES (July 22, 1993)
  • 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)
  • K850270 — CORNEAL LIGHT SHIELD (May 31, 1985)

FDA data resources