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Luneau

LUNEAU TECHNOLOGY OPERATIONS · Model Tonometer separation prisms L900 -box of 100 · UDI-DI 03664188000107

HKY Prescription
1
510(k) clearances
11
Adverse events
2
Recalls
64
Facilities

Description

The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.

Recalls

DateFirmReason
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a
2014-09-08Instrumed International, Inc.The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet a

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.