FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZEISS OPMILAS 144 SURGICAL LASERS
K Number: K942439
·
Decision Jul 1, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
112
Basic Information
- Device Name
- ZEISS OPMILAS 144 SURGICAL LASERS
- K Number
- K942439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ZEISS HUMPHREY SYSTEM
- Date Received
- March 11, 1994
- Decision Date
- July 1, 1994
- 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 |
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Other Clearances by ZEISS HUMPHREY SYSTEM
| K Number | Device Name | ||
|---|---|---|---|
| K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE | Nov 8, 1993 | Substantially Equivalent |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | Dec 10, 1992 | Substantially Equivalent |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | Sep 18, 1985 | Substantially Equivalent |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | Aug 12, 1985 | Substantially Equivalent |
| K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 | Jul 28, 1982 | Substantially Equivalent |
| K802029 | OBJECTIVE REFRACTOR | Nov 12, 1980 | Substantially Equivalent |
| K781994 | AUTOKERATOMETER, INSTRUMENT | Feb 12, 1979 | Substantially Equivalent |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Jan 26, 1979 | Substantially Equivalent |