ASMOTOM AUTOMATED TREPHINE SYSTEM
FDA 510(k) clearance K013151 · decided 2001-12-14
Clearance details
- K-number
- K013151
- Device name
- ASMOTOM AUTOMATED TREPHINE SYSTEM
- Applicant
- Bkg Opthalmics USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-20
- Decision date
- 2001-12-14
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- HRG
- Device class
- 1
- Regulation number
- 886.4070
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AUTOMATED CORNEAL TREPHINE (K981063) | Laser Center Dev. Corp. | 1998-06-23 |
| ULTRATHIN/SP LENS (K843957) | Optical Systems Intl., Inc. | 1985-07-31 |
| SCANLAN VASCU-STATT II (K841515) | Scanlan Intl., Inc. | 1984-06-05 |
| TREPHINE BLADES-VARIOUS MODELS (K823901) | Edward Weck, Inc. | 1983-01-17 |
| (MICRO-KERATRON, MICRO DUCT TREPHINE) (K791763) | Intl. Ophthalmic Industries Corp. | 1979-11-05 |
Recalls involving this device
No recalls on record reference this clearance.