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510(k) K913961

OPHTHALMIC STAND by Luneau Ophtalmologie SA — Product Code HMF

K913961 is an FDA 510(k) premarket notification submitted by Luneau Ophtalmologie SA for the device "OPHTHALMIC STAND". The FDA issued a decision of Substantially Equivalent on December 4, 1991. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. Luneau Ophtalmologie SA has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1991
Date Received
September 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stand, Instrument, Ac-Powered, Ophthalmic
Device Class
Class I
Regulation Number
886.1860
Review Panel
OP
Submission Type

Other clearances by Luneau Ophtalmologie SA

  • K922253 — KERATOREF L60 (June 19, 1992)
  • K921214 — OPHTHALMIC PROJECTOR (June 11, 1992)

Other clearances for product code HMF

  • K935952 — ROTA SYSTEM 5000 (April 19, 1994)
  • K935945 — ROTA DATAMATE I (April 19, 1994)
  • K931839 — ROTA SYSTEM XL (November 22, 1993)
  • K930440 — MARCO INTERNATIONAL STAND (July 6, 1993)
  • K924780 — BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (April 5, 1993)
  • K924771 — BURTON OPHTHALMIC STAND - MODEL XL3200 (April 5, 1993)
  • K853358 — RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (October 4, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)
  • K832073 — ELECTRIC INSTRUMENT TABLE (August 12, 1983)

FDA data resources