FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHACO 20/20 SYSTEM I
K Number: K915457
·
Decision Feb 24, 1992
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
22
Review Days
81
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Basic Information
- Device Name
- PHACO 20/20 SYSTEM I
- K Number
- K915457
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- December 5, 1991
- Decision Date
- February 24, 1992
- 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 |
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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+
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Other Clearances by Innovative Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973035 | VIOLA II DENTAL CAMERA SYSTEM | Sep 24, 1997 | Substantially Equivalent |
| K951469 | BAZOOKA SYSTEM | Jun 28, 1995 | Substantially Equivalent |
| K933184 | POSITIVE AIRWAY PRESSURE SYSTEM | Nov 28, 1994 | Substantially Equivalent |
| K924590 | MICROWAVE AUTOMATED TISSUE PROCESSOR | Dec 29, 1992 | Substantially Equivalent |
| K922081 | LABOTECH AUTOMATED MICROTITER ANALYZER | Sep 2, 1992 | Substantially Equivalent |
| K921005 | AUTOLOADER | Apr 29, 1992 | Substantially Equivalent |
| K915456 | PHACO 3000 LINEAR | Feb 12, 1992 | Substantially Equivalent |
| K883599 | LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) | Sep 2, 1988 | Substantially Equivalent |
| K880745 | LX-100 SLIDE STAINER | Apr 27, 1988 | Substantially Equivalent |
| K853938 | LX 300 TISSUE PROCESSOR | Oct 10, 1985 | Substantially Equivalent |