Product code MYD
- Device name
- Keratome, Water Jet
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4370
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991124 | VISIJET HYDROKERATOME, MODEL 50 | Visijet, Inc. | 2000-10-20 |