510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955900Substantially Equivalent

Novalens/novawet Sphjerical & Perception & Vanguard Multifocal &/or Bifocal (Rosifocon a) Rigid Gas Permeable Contact Lr

Novavision, Inc., Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955900 is the FDA 510(k) clearance record for NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR, a class II device, cleared for Novavision, Inc. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list 3 510(k) clearances for Novavision, Inc., from to . As of , FDA records show no recalls naming K955900.

Clearance record

Decision date
Received
(87 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Novavision, Inc. 2700-200 Gateway Centre Blvd., Morrisville NC
510(k) summary
Statement
Third party review
No

Clearances, product code HQD

Trailing 12 months
1 clearance under product code HQD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260