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510(k) K844363

OPHTHALMIC STAND by Luneau Laboratories — Product Code HMF

K844363 is an FDA 510(k) premarket notification submitted by Luneau Laboratories for the device "OPHTHALMIC STAND". The FDA issued a decision of Substantially Equivalent on December 5, 1984. The device falls under product code HMF (Stand, Instrument, Ac-Powered, Ophthalmic), a Class I device regulated under 21 CFR 886.1860. Luneau Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1984
Date Received
November 13, 1984
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 Laboratories

  • K850068 — LUNE AU CURETTES (April 8, 1985)
  • K844364 — SKIASCOPIC RACKS (January 2, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)

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)
  • K913961 — OPHTHALMIC STAND (December 4, 1991)
  • K853358 — RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (October 4, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K832073 — ELECTRIC INSTRUMENT TABLE (August 12, 1983)

FDA data resources