FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DC-3300 LASER DIODE PHOTOCOAGULATOR
K Number: K013760
·
Decision Feb 11, 2002
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
77
Review Days
90
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Basic Information
- Device Name
- DC-3300 LASER DIODE PHOTOCOAGULATOR
- K Number
- K013760
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek, Inc.
- Date Received
- November 13, 2001
- Decision Date
- February 11, 2002
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K020876 | ECHOSCAN, MODEL US-1800 | May 3, 2002 | Substantially Equivalent |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Apr 17, 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 |