FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALCON(R) FX2(TM) PHOTOCOAGULATOR
K Number: K914334
·
Decision Nov 13, 1992
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
47
Review Days
413
Basic Information
- Device Name
- ALCON(R) FX2(TM) PHOTOCOAGULATOR
- K Number
- K914334
- 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
- ALCON LABORATORIES
- Date Received
- September 27, 1991
- Decision Date
- November 13, 1992
- 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 ALCON LABORATORIES
| K Number | Device Name | ||
|---|---|---|---|
| K062624 | NEXT GENERATION LASER | Nov 5, 2007 | Substantially Equivalent |
| K062865 | SMALL VOLUME SYRINGE | Aug 23, 2007 | Substantially Equivalent |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Apr 11, 2000 | Substantially Equivalent |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Sep 16, 1999 | Substantially Equivalent |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | May 10, 1999 | Substantially Equivalent |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Jan 14, 1999 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Dec 18, 1998 | Substantially Equivalent |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K981561 | LIQUID ENZYME ID 90133 | Jul 24, 1998 | Substantially Equivalent |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Jul 9, 1998 | Substantially Equivalent |