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510(k) K951552

BOSTON CONTACT LENS CASE by Polymer Technology Corp. — Product Code LRX

K951552 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "BOSTON CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on June 26, 1995. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1995
Date Received
April 4, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Polymer Technology Corp.

  • K011945 — RIGID GAS PERMEABLE CONTACT LENS SOLUTION (September 12, 2001)
  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 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)

Other clearances for product code LRX

  • K252175 — LANDR Contact LENS Case (February 10, 2026)
  • K250495 — MINI VP1 (PL67_F); MINI VP1 (PL61_F) (August 1, 2025)
  • K240095 — CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) (October 9, 2024)
  • K231123 — Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Cas (August 30, 2023)
  • K173538 — Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (December 4, 2017)
  • K172925 — Contact Lens Case, Model: A-1, B-1 (November 30, 2017)
  • K173365 — Bausch + Lomb Boston Scleral Lens Case (November 17, 2017)
  • K171539 — Contact Lens Case (July 14, 2017)
  • K171163 — Contact Lens Case Round Glasses (June 27, 2017)
  • K162869 — Contact Lens Case (December 9, 2016)

FDA data resources