FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHACOPAK
K Number: K974719
·
Decision Jan 20, 1998
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
10
Review Days
33
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PHACOPAK
- K Number
- K974719
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Paradigm Medical Industries, Inc.
- Date Received
- December 18, 1997
- Decision Date
- January 20, 1998
- Product Code
- HQC
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HQC | Unit, Phacofragmentation | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQC), ordered by most recent decision 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+
FDA 510(k)
FDA Class 2
·Ophthalmic
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
FDA 510(k)
FDA Class 2
·Ophthalmic
System Sophi
FDA 510(k)
FDA Class 2
·Ophthalmic
MICOR 700 with Auto I/A
FDA 510(k)
FDA Class 2
·Ophthalmic
MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
FDA 510(k)
FDA Class 2
·Ophthalmic
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Paradigm Medical Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050980 | ULTRASONIC BIO-MICROSCOPE, MODEL P60 | May 26, 2005 | Substantially Equivalent |
| K023245 | BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 | Oct 21, 2002 | Substantially Equivalent |
| K003318 | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X | May 22, 2001 | Substantially Equivalent |
| K003141 | UBM PLUS, MODEL P45 | Dec 5, 2000 | Substantially Equivalent |
| K002228 | PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X | Oct 6, 2000 | Substantially Equivalent |
| K981109 | QUITETIP | Jun 9, 1998 | Substantially Equivalent |
| K971795 | AUTOMATED CHAMBER MAINTENANCE MODULE | Jul 14, 1997 | Substantially Equivalent |
| K970887 | BLOOD FLOW ANALYZER | Jun 17, 1997 | Substantially Equivalent |
| K953447 | PRECISIONIST THIRTY THOUSAND | Oct 13, 1995 | Substantially Equivalent |