510(k) K003512
- Device
- LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
- Applicant
- A.R.C. LASER AG
- 510(k) number
- K003512
- Product code
- HQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-02-08
- Date received
- 2000-11-14
- Regulation
- 886.4670
- Classification name
- Unit, Phacofragmentation
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL HOEFER
- Address
- 2417 S. 3850 W. Salt Lake City UT US 84120 84120
FDA Registration Numbers#
- 1058584
- 3006695864
- 3009732568
- 1932180
- 1722139
- 3015456951
- 3019924
- 3003398873
- 3007007790
- 3008102042
- 1047843
- 2935428
- 3013875599
- 1526711
- 9681121
- 1649518
- 3033485955
- 9615010
- 9681572
- 1932402
- 1928237
- 8030967
- 1319429
- 1920664
- 8010510
- 1036836
- 3008692839
- 3012236936
- 1644019
- 3007606649
- 3002807090
- 1317547
- 2523835
- 1054713
- 3010162782
- 3010047402
- 2029275
- 9611516
- 1424263
- 2028159
- 1319660
- 2085081
- 3007867838
- 1650907
- 2246552
- 3009026057
- 3005941719
- 3010208880
- 3029990829
- 2529392
- 1720929
- 2032098
- 3015528097
- 3007648309
- 3012132406
- 1313525
- 3003365815
- 3042928348
- 3010220595
- 3016245399
- 3012123033
- 3029973819
- 3009337401
- 3007344957
- 3006946276
- 3010160527
- 3004636440
- 3010291427
- 3013497605
- 3005012805
- 2126666
- 3014256632
- 2025303
Source Documents#
Other 510(k) Records For Product Code HQC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261264 | 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™+ | Bausch and Lomb | 2026-05-15 |
| K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) | Bausch and Lomb, Incorporated | 2026-03-25 |
| K250501 | System Sophi | This AG | 2025-11-14 |
| K243395 | MICOR 700 with Auto I/A | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-08-08 |
| K242801 | MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 |
| K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) | Bausch and Lomb, Incorporated | 2024-07-26 |
| K233398 | Faros Surgical System | Oertli Instrumente AG | 2024-06-27 |
| K233876 | UNITY VCS (8065000296); UNITY CS (8065000297) | Alcon Laboratories, Inc. | 2024-06-21 |
| K232084 | Stellaris Elite vision enhancement system | Bausch and Lomb | 2024-02-26 |
| K233902 | Centurion™ Vision System (Active Sentry™) (8065753057) | Alcon Laboratories, Inc. | 2024-01-10 |
| K230858 | QUATERA 700 | Carl Zeiss Meditec, AG | 2023-07-31 |
| K214028 | MICOR Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 |
| K222236 | miCOR System Lens Fragmentation System | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 |
| K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 |
| K212241 | QUATERA 700 | Carl Zeiss Meditec, AG | 2022-04-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases