Home / 510(k) Clearances / K162067

510(k) K162067

VX130 Ophthalmic Diagnostic Device by Luneau Sas — Product Code HKX

K162067 is an FDA 510(k) premarket notification submitted by Luneau Sas for the device "VX130 Ophthalmic Diagnostic Device". The FDA issued a decision of Substantially Equivalent on April 24, 2017. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Luneau Sas has at least 4 other 510(k) clearances on record.

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

  • K143086 — VX120 Ophthalmic Diagnostic Device (June 1, 2015)
  • 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

  • K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (November 7, 2025)
  • K223739 — VS Tabletop Tonometer (November 8, 2023)
  • 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)

FDA data resources