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510(k) K023045

MICRORUPTER V by Meridian AG — Product Code LXS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2002
Date Received
September 12, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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

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  • K160677 — MICRORUPTOR 6 (May 19, 2017)
  • K113390 — LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500) (February 14, 2012)
  • K072823 — MERILAS 532A (December 14, 2007)

Other clearances for product code LXS

  • 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)
  • K892058 — ISL QC 2000 (June 15, 1989)