FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
AMER. MEDICAL OPTICS DIGITAL KERATO-
K Number: K842504
·
Decision Oct 1, 1984
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
4
Applicant Total
17
Review Days
97
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Basic Information
- Device Name
- AMER. MEDICAL OPTICS DIGITAL KERATO-
- K Number
- K842504
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Medical Optics
- Date Received
- June 26, 1984
- Decision Date
- October 1, 1984
- Product Code
- HQL
- 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 |
|---|---|---|---|
| HQL | Intraocular Lens | FDA class 3 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HQL), ordered by most recent decision date.
CHIROFLEX II LENS MICROSERT(TM)
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SOFTRANS INJECTOR
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NIDEK DIGITAL KERATOMETER
FDA 510(k)
FDA Class 3
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CILCO ANTERIOR CHAMBER LENS
FDA 510(k)
FDA Class 3
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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 |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | Nov 8, 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 |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | Sep 7, 1984 | Substantially Equivalent |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | Aug 15, 1984 | Substantially Equivalent |