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510(k) K003933

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY by Polymer Technology — Product Code MUW

K003933 is an FDA 510(k) premarket notification submitted by Polymer Technology for the device "BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY". The FDA issued a decision of Substantially Equivalent on February 16, 2001. The device falls under product code MUW (Lens, Contact (Orthokeratology)), a Class II device regulated under 21 CFR 886.5916. Polymer Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2001
Date Received
December 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Orthokeratology)
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

Other clearances by Polymer Technology

  • K011945 — RIGID GAS PERMEABLE CONTACT LENS SOLUTION (September 12, 2001)
  • K003932 — BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K002025 — RIGID GAS PERMEABLE CONTACT LENS (October 31, 2000)
  • K001960 — RIGID GAS PERMEABLE CONTACT LENS (August 28, 2000)
  • K000795 — RIGID GAS PERMEABLE CONTACT LENS (May 26, 2000)
  • K980133 — BAUSCH & LOMB WETTING AND SOAKING SOLUTION (March 11, 1998)
  • K974466 — BOSTON ADVANCE CLEANER (February 19, 1998)
  • K973217 — BOSTON LIQUID ENZYMATIC CLEANER (November 24, 1997)
  • K970698 — BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS (May 6, 1997)
  • K951552 — BOSTON CONTACT LENS CASE (June 26, 1995)

Other clearances for product code MUW

  • K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (January 9, 2019)
  • K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (July 13, 2016)
  • K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK (February 28, 2001)
  • K000224 — FLUROPERM 60-OK, PARAGON HDS-OK (April 17, 2000)
  • K973697 — AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTH (April 8, 1998)

FDA data resources