Atlas FDA

VENTURI PHACO PACK

FDA 510(k) clearance K033653 · decided 2003-12-17

Clearance details

K-number
K033653
Device name
VENTURI PHACO PACK
Applicant
Bausch & Lomb, Inc.
Decision
Substantially Equivalent
Date received
2003-11-21
Decision date
2003-12-17
Days to decision
26 days
Clearance type
Special
Product code
HQC
Device class
2
Regulation number
886.4670
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
St. Louis, MO, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Bausch & Lomb

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ (K261264)Bausch and Lomb2026-05-15
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052)Bausch and Lomb, Incorporated2026-03-25
System Sophi (K250501)This AG2025-11-14
MICOR 700 with Auto I/A (K243395)Carl Zeiss Meditec Cataract Technology, Inc.2025-08-08
MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (K242801)Carl Zeiss Meditec Cataract Technology, Inc.2025-06-11
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (K240169)Bausch and Lomb, Incorporated2024-07-26
Faros Surgical System (K233398)Oertli Instrumente AG2024-06-27
UNITY VCS (8065000296); UNITY CS (8065000297) (K233876)Alcon Laboratories, Inc.2024-06-21
Stellaris Elite vision enhancement system (K232084)Bausch and Lomb2024-02-26
Centurion™ Vision System (Active Sentry™) (8065753057) (K233902)Alcon Laboratories, Inc.2024-01-10
QUATERA 700 (K230858)Carl Zeiss Meditec, AG2023-07-31
MICOR Lens Fragmentation System (K214028)Carl Zeiss Meditec Cataract Technology, Inc.2022-09-09

Recalls involving this device

RecordFirmDate
Bausch & Lomb Millennium Basic Venturi Phaco Pack, Models DP4305 and DP4305E, 12 packs/box recall (Z-1708-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Millennium Premium Venturi Phaco Pack, Model DP4310 and DP4310E, 6 packs/box recall (Z-1709-2010)Bausch & Lomb Inc2010-05-28
Bausch & Lomb Millennium Micro Incision Premium Venturi Pack, Model CX4320, 6 packs/box, R recall (Z-1711-2010)Bausch & Lomb Inc2010-05-28

PMA approvals by this applicant

RecordFirmDate
Bausch & Lomb SofLens® (polymacon) Contact Lenses (N16895/S107)Bausch & Lomb, Inc.2025-10-24
Akreos Posterior Chamber Intraocular Lens (P060022/S037)Bausch & Lomb, Inc.2025-09-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S003)Bausch & Lomb, Inc.2025-07-30
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S036)Bausch & Lomb, Inc.2025-07-22
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S035)Bausch & Lomb, Inc.2025-07-09
enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S060)Bausch & Lomb, Inc.2025-06-18
enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S059)Bausch & Lomb, Inc.2025-05-30
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S004)Bausch & Lomb, Inc.2025-05-30