FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
K Number: K843966
·
Decision Nov 8, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
17
Review Days
28
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Basic Information
- Device Name
- ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS
- K Number
- K843966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Medical Optics
- Date Received
- October 11, 1984
- Decision Date
- November 8, 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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Other Clearances by American Medical Optics
| K Number | Device Name | ||
|---|---|---|---|
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | Feb 4, 1986 | Substantially Equivalent |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | May 1, 1985 | Substantially Equivalent |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | May 1, 1985 | Substantially Equivalent |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | Apr 30, 1985 | Substantially Equivalent |
| K844150 | MEDICAL OPTICS PHACOEMULSIFICATION KIT | Dec 11, 1984 | Substantially Equivalent |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | Nov 6, 1984 | Substantially Equivalent |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | Oct 1, 1984 | Substantially Equivalent |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | Oct 1, 1984 | Substantially Equivalent |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | Sep 7, 1984 | Substantially Equivalent |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | Aug 15, 1984 | Substantially Equivalent |