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Fsa 52

by Paragon Vision Sciences

Fsa 52 is a Class II device made by Paragon Vision Sciences, cleared under FDA 510(k) K013310 on 25 Apr 2002 and listed in FDA GUDID since 16 Mar 2018 (UDI-DI B22214), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K013310

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB22214 UDI-DI Date16 Mar 2018ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013310 Date25 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013310 decided 25 Apr 2002 Active
  • FDA GUDID UDI-DI B22214 listed 16 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013310
  2. Listed FDA GUDID B22214

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Model / reference
FSA 52
Primary DI / UDI-DI
B22214
FDA product code
HQD
GMDN term
Rigid-gas-permeable corrective contact lens, daily-wear, non-customized
Device class
Class II
Regulation number
886.5916
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Rigid-gas-permeable corrective contact lens, daily-wear

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 →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)