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510(k) K892058

ISL QC 2000 by Intelligent Surgical Lasers, Inc. — Product Code LXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 1989
Date Received
March 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Device Class
Class II
Regulation Number
886.4392
Review Panel
OP
Submission Type

Other clearances by Intelligent Surgical Lasers, Inc.

  • K941694 — ISL QC 2000 LASER (May 12, 1994)

Other clearances for product code LXS

  • K023045 — MICRORUPTER V (September 26, 2002)
  • K901605 — PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA. (December 13, 1990)
  • K895864 — MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP (December 29, 1989)
  • K893987 — NIDEK MODEL YC-1200 (August 18, 1989)
  • K892204 — NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS (June 22, 1989)