Home / 510(k) Clearances / K994170

510(k) K994170

HYLASHIELD CL by Biomatrix, Inc. — Product Code MRC

K994170 is an FDA 510(k) premarket notification submitted by Biomatrix, Inc. for the device "HYLASHIELD CL". The FDA issued a decision of Substantially Equivalent on March 2, 2000. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Biomatrix, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2000
Date Received
December 10, 1999
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 Biomatrix, Inc.

  • K993362 — HYLASINE (March 13, 2000)

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