FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K Number: K844197
·
Decision Dec 24, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
77
Review Days
55
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Basic Information
- Device Name
- ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
- K Number
- K844197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Nidek, Inc.
- Date Received
- October 30, 1984
- Decision Date
- December 24, 1984
- Product Code
- HQB
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| 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 |