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510(k) K162067

VX130 Ophthalmic Diagnostic Device by Luneau Sas — Product Code HKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2017
Date Received
July 26, 2016
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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  • K023838 — LUNEAU STERILE TONOMETER SEPARATION PRISMS (February 20, 2003)
  • K022413 — LUNEAU 3 MIRROR LENS (September 24, 2002)
  • K851557 — ANESTHESIOMETER (May 30, 1985)

Other clearances for product code HKX

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  • K190382 — Intraocular Pressure Tonometer EASYTON (December 6, 2019)
  • 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)
  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • 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)