FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
K Number: K900166
·
Decision Mar 27, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
77
Review Days
74
Basic Information
- Device Name
- NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS
- K Number
- K900166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- NIDEK, INC.
- Date Received
- January 12, 1990
- Decision Date
- March 27, 1990
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by NIDEK, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K050336 | OPD-STATION SOFTWARE | Aug 24, 2005 | Substantially Equivalent |
| K042785 | MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 | Dec 14, 2004 | Substantially Equivalent |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Dec 4, 2003 | Substantially Equivalent |
| K032085 | GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 | Oct 3, 2003 | Substantially Equivalent |
| K013694 | NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) | Nov 19, 2002 | Substantially Equivalent |
| K020876 | ECHOSCAN, MODEL US-1800 | May 3, 2002 | Substantially Equivalent |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Apr 17, 2002 | Substantially Equivalent |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Feb 11, 2002 | Substantially Equivalent |
| K013864 | MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 | Feb 8, 2002 | Substantially Equivalent |
| K990119 | EPI-STAR SURGICAL LASER SYSTER | Jul 27, 2000 | Substantially Equivalent |