FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K Number: K984143
·
Decision Feb 16, 1999
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
10
Review Days
90
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Basic Information
- Device Name
- FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
- K Number
- K984143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fibra Sonics, Inc.
- Date Received
- November 18, 1998
- Decision Date
- February 16, 1999
- 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 Fibra Sonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Nov 22, 1999 | Substantially Equivalent |
| K984199 | EXONIX | Feb 17, 1999 | Substantially Equivalent |
| K983199 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL | Dec 14, 1998 | Substantially Equivalent |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | Sep 22, 1998 | Substantially Equivalent |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Dec 11, 1984 | Substantially Equivalent |
| K834453 | PHACO FRAGMENTOR GT-1 | Mar 16, 1984 | Substantially Equivalent |
| K813389 | ULTRASONIC FRAGMENTOR | Feb 4, 1982 | Substantially Equivalent |
| K812909 | HYGIENTIST; CYCLOSON I & II; RETROFIT | Dec 14, 1981 | Substantially Equivalent |
| K802381 | LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. | Dec 17, 1980 | Substantially Equivalent |