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510(k) K974466

BOSTON ADVANCE CLEANER by Polymer Technology Corp. — Product Code MRC

K974466 is an FDA 510(k) premarket notification submitted by Polymer Technology Corp. for the device "BOSTON ADVANCE CLEANER". The FDA issued a decision of Substantially Equivalent on February 19, 1998. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Polymer Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1998
Date Received
November 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type

Other clearances by Polymer Technology Corp.

  • K011945 — RIGID GAS PERMEABLE CONTACT LENS SOLUTION (September 12, 2001)
  • K003932 — BOSTON EO (ENFLUFOCON B) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) 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)
  • 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 MRC

  • K251876 — cleadew GP hydra one (October 9, 2025)
  • K200416 — Boston One Step Liquid Enzymatic Cleaner (September 23, 2020)
  • K201069 — VibrantVue Scleral Saline (July 31, 2020)
  • K182984 — MaxiTears Contacts PF (July 24, 2019)
  • K181566 — Nutrifill (October 22, 2018)
  • K181627 — Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step (August 10, 2018)
  • K180319 — Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning (March 27, 2018)
  • K173089 — Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditionin (November 27, 2017)
  • K173136 — Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (November 16, 2017)
  • K130805 — MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (July 3, 2013)

FDA data resources