FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TBD, LENS MEASURING DEVICE
K Number: K912134
·
Decision Jul 25, 1991
Classifications
1
FEI Numbers
54
Registration Numbers
55
Same Product Code
6
Applicant Total
47
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- TBD, LENS MEASURING DEVICE
- K Number
- K912134
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4855
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Alcon Laboratories
- Date Received
- May 14, 1991
- Decision Date
- July 25, 1991
- Product Code
- HRJ
- 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 |
|---|---|---|---|
| HRJ | Table, Instrument, Powered, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRJ), ordered by most recent decision date.
MARCO H AND TS-1 INSTRUMENT TABLES
FDA 510(k)
FDA Class 1
·Ophthalmic
910T MONTORIZED INSTRUMENT TABLE
FDA 510(k)
FDA Class 1
·Ophthalmic
TECHNA VISION, INC.ELECTRIC TABLE
FDA 510(k)
FDA Class 1
·Ophthalmic
RELIANCE 1379
FDA 510(k)
FDA Class 1
·Ophthalmic
WOODLYN CLASSIC INSTRUMENT STAND
FDA 510(k)
FDA Class 1
·Ophthalmic
MACHEMER/TANO ROTATING
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | 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 |