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510(k) K143086

VX120 Ophthalmic Diagnostic Device by Luneau Sas — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2015
Date Received
October 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tonometer, Ac-Powered
Device Class
Class II
Regulation Number
886.1930
Review Panel
OP
Submission Type

Other clearances by Luneau Sas

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  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)
  • K851557 — ANESTHESIOMETER (May 30, 1985)

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  • K181260 — MiiS Horus Scope DPT 100 (June 21, 2019)
  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K180820 — Tono Vue Non-Contact Tonometer (December 14, 2018)
  • K162067 — VX130 Ophthalmic Diagnostic Device (April 24, 2017)
  • K113066 — CORVIS ST (November 8, 2012)
  • K111710 — FULL AUTO TONOMETER MODEL TX-20 (September 20, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)