Atlas FDA

PARAGON LENS CARE

FDA 510(k) clearance K974635 · decided 1998-02-04

Clearance details

K-number
K974635
Device name
PARAGON LENS CARE
Applicant
Paragon Vision Sciences
Decision
Substantially Equivalent
Date received
1997-12-12
Decision date
1998-02-04
Days to decision
54 days
Clearance type
Traditional
Product code
LRX
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Mesa, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S055)Paragon Vision Sciences1994-01-04
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S056)Paragon Vision Sciences1994-01-04
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S054)Paragon Vision Sciences1993-04-14
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S053)Paragon Vision Sciences1992-11-25
OPTACRYL 60 (KOLFOCON A)RGP BROWN TINT (P820056/S051)Paragon Vision Sciences1992-06-11
OPTACRYL 60 (KOLFOCON A)RGP CONTACT LENS (P820056/S052)Paragon Vision Sciences1992-03-30
OPTACRYL 60 (KOLFOCON A)RGP FINISHING LABS (P820056/S050)Paragon Vision Sciences1992-02-25
OPTACRYL 60 - CLEAR (P820056/S049)Paragon Vision Sciences1991-08-15