Home / 510(k) Clearances / K082473

510(k) K082473

BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM by Bausch & Lomb, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2009
Date Received
August 27, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

Other clearances by Bausch & Lomb, Inc.

  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K192005 — Bausch + Lomb PreVue Inserter for enVista Preloaded (October 4, 2019)
  • K173480 — Crystalsert Lens Delivery System (December 11, 2017)
  • K151102 — Bausch + Lomb Injector System (May 22, 2015)
  • K133486 — STELLARIS PC VISION ENHANCEMENT SYSTEM (March 12, 2014)
  • K133242 — STELLARIS VISION ENHANCEMENT SYSTEM (February 14, 2014)
  • K131958 — BAUSCH & LOMB INJECTOR SYSTEM (January 9, 2014)
  • K133146 — BAUSCH + LUMB, VIS100 INJECTOR SYSTEM (January 3, 2014)
  • K132481 — EASY-LOAD LENS DELIVERY SYSTEM (December 27, 2013)
  • K132593 — CRYSTALSERT DELIVERY SYSTEM (September 17, 2013)

Other clearances for product code HQC

  • K250501 — System Sophi (November 14, 2025)
  • K243395 — MICOR 700 with Auto I/A (August 8, 2025)
  • K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-5062 (June 11, 2025)
  • K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (July 26, 2024)
  • K233398 — Faros Surgical System (June 27, 2024)
  • K233876 — UNITY VCS (8065000296); UNITY CS (8065000297) (June 21, 2024)
  • K232084 — Stellaris Elite vision enhancement system (February 26, 2024)
  • K233902 — Centurion™ Vision System (Active Sentry™) (8065753057) (January 10, 2024)
  • K230858 — QUATERA 700 (July 31, 2023)
  • K214028 — MICOR Lens Fragmentation System (September 9, 2022)