Atlas FDA

KONTUR 55 SOFT LENS

FDA 510(k) clearance K001908 · decided 2000-08-18

Clearance details

K-number
K001908
Device name
KONTUR 55 SOFT LENS
Applicant
Kontur Kontact Lens Co., Inc.
Decision
Substantially Equivalent
Date received
2000-06-22
Decision date
2000-08-18
Days to decision
57 days
Clearance type
Traditional
Product code
LPL
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Lafayette, CO, 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
KONTUR SOFT (METHAFILCON A) LENS (P850078/S013)Kontur Kontact Lens Co., Inc.1990-01-03
KONTUR SOFT (METHAFILCON A) LENS (P850078/S012)Kontur Kontact Lens Co., Inc.1989-12-11
KONTUR SOFT (METHAFILCON A) LENS (P850078/S010)Kontur Kontact Lens Co., Inc.1989-03-14
KONTUR SOFT (METHAFILCON A) LENS (P850078/S006)Kontur Kontact Lens Co., Inc.1987-12-01
KONTUR SOFT (METHAFILCON A) LENS (P850078/S007)Kontur Kontact Lens Co., Inc.1987-09-30
KONTUR SOFT (METHAFILCON A) LENS (P850078/S003)Kontur Kontact Lens Co., Inc.1987-09-28
KONTUR SOFT (METHAFILCON A) LENS (P850078/S004)Kontur Kontact Lens Co., Inc.1987-09-28
KONTUR SOFT (METHAFILCON A) LENS (P850078/S008)Kontur Kontact Lens Co., Inc.1987-08-10