MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
FDA 510(k) clearance K940088 · decided 1994-08-04
Clearance details
- K-number
- K940088
- Device name
- MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
- Applicant
- Medical Technical Products
- Decision
- Substantially Equivalent
- Date received
- 1994-01-07
- Decision date
- 1994-08-04
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| 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 Lomb | 2026-05-15 |
| Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (K252052) | Bausch and Lomb, Incorporated | 2026-03-25 |
| System Sophi (K250501) | This AG | 2025-11-14 |
| 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, Incorporated | 2024-07-26 |
| Faros Surgical System (K233398) | Oertli Instrumente AG | 2024-06-27 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Stellaris Elite vision enhancement system (K232084) | Bausch and Lomb | 2024-02-26 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| QUATERA 700 (K230858) | Carl Zeiss Meditec, AG | 2023-07-31 |
| MICOR Lens Fragmentation System (K214028) | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-09-09 |
Recalls involving this device
No recalls on record reference this clearance.