Home / 510(k) Clearances / K202932

510(k) K202932

ABT12 multi-purpose solution by Bausch & Lomb, Incorporated — Product Code LPN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2021
Date Received
September 29, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Soft Lens Products
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type

Other clearances by Bausch & Lomb, Incorporated

  • K242389 — EyeGility™ Inserter for Preloaded enVista IOLs (October 10, 2024)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K220613 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kal (March 8, 2023)
  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K210975 — Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (May 24, 2021)
  • K200416 — Boston One Step Liquid Enzymatic Cleaner (September 23, 2020)
  • K183167 — Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon (February 12, 2019)
  • K182249 — Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (November 30, 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)

Other clearances for product code LPN

  • K222541 — Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (December 6, 2022)
  • K221263 — Aqua Naina Plus Sterile Saline Solution (October 12, 2022)
  • K210051 — OTE MPS 045 Multi-purpose Lens Care Solution (May 26, 2021)
  • K193441 — Aqua Naina Sterile Saline Solution (May 26, 2020)
  • K200747 — PuriLens Plus Preservative Free Saline (May 15, 2020)
  • K191872 — Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (March 2, 2020)
  • K190674 — REFRESH RELIEVA For CONTACTS (August 8, 2019)
  • K191795 — AOCup Lens Case with AODisc (July 31, 2019)
  • K170483 — Bausch + Lomb Sensitive Eyes Plus Saline Solution (April 11, 2017)
  • K161819 — NNR06 Multi-Purpose Solution (November 25, 2016)