FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
K Number: K042785
·
Decision Dec 14, 2004
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
77
Review Days
69
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
- MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
- K Number
- K042785
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek, Inc.
- Date Received
- October 6, 2004
- Decision Date
- December 14, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Nidek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050336 | OPD-STATION SOFTWARE | Aug 24, 2005 | 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 |
| K990900 | MICROKERATOME, MODEL MK-2000 | Sep 24, 1999 | Substantially Equivalent |