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510(k) K912130

TBD KERATOSCOPE by Alcon Laboratories — Product Code HLQ

K912130 is an FDA 510(k) premarket notification submitted by Alcon Laboratories for the device "TBD KERATOSCOPE". The FDA issued a decision of Substantially Equivalent on August 9, 1991. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Alcon Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1991
Date Received
May 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

Other clearances by Alcon Laboratories

  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • 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 HLQ

  • K003299 — OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (March 9, 2001)
  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (December 7, 1994)
  • K944616 — KERATRON CORNEAL TOPOGRAPHER (November 22, 1994)
  • K940647 — ORBSCAN(TM) KERATOMETER (July 6, 1994)
  • K933556 — EH-270 CORNEAL TOPOGRAPHER (November 2, 1993)
  • K923435 — CORNEAL TOPOGRAPHY SYSTEM (February 16, 1993)
  • K922253 — KERATOREF L60 (June 19, 1992)

FDA data resources