FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMS SLIMLINE PHACO HANDPIECE
K Number: K950218
·
Decision Jul 17, 1995
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
315
Applicant Total
21
Review Days
179
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Basic Information
- Device Name
- OMS SLIMLINE PHACO HANDPIECE
- K Number
- K950218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4670
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Optical Micro Systems, Inc.
- Date Received
- January 19, 1995
- Decision Date
- July 17, 1995
- 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 Optical Micro Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946054 | DIPLOMAX | Jul 11, 1995 | Substantially Equivalent |
| K935223 | OPHTHALMIC SURGICAL SYSTEM | Mar 14, 1994 | Substantially Equivalent |
| K935226 | I/V POLE | Feb 16, 1994 | Substantially Equivalent |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Jan 25, 1994 | Substantially Equivalent |
| K870068 | ASPIRATION REVERSAL CONTROL (ARC) MODULE | Feb 12, 1987 | Substantially Equivalent |
| K844373 | O.M.S. ULTRA-PHACO | Dec 19, 1985 | Substantially Equivalent |
| K844448 | OMS/GONVERS RETINAL PERFORATOR | Aug 21, 1985 | Substantially Equivalent |
| K844895 | OMS SILICONE OIL INJECTOR | Jun 24, 1985 | Substantially Equivalent |
| K844467 | OMS CRYO | Feb 22, 1985 | Substantially Equivalent |
| K844715 | VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY | Jan 22, 1985 | Substantially Equivalent |