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Pvs Basics

by Paragon Vision Sciences

510(k) K984436

Pvs Basics is a Class II device made by Paragon Vision Sciences, cleared under FDA 510(k) K984436 on 21 Apr 1999, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984436 Date21 Apr 1999ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HQD
Device class
Class II
Regulation
21 CFR Part 886.5916
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Devices cleared under K984436

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K984436
UDI-DISize and differences
FSA 38
Paragon Vision Sciences
FSA 38B22211 —No longer on the market

Similar devices

Other devices filed under FDA product code HQD (Lens, Contact (Other Material) - Daily).

Other devices from Paragon Vision Sciences

See all devices from Paragon Vision Sciences →