FLUID ISOLATION DEVICE
FDA 510(k) clearance K091915 · decided 2009-10-27
Clearance details
- K-number
- K091915
- Device name
- FLUID ISOLATION DEVICE
- Applicant
- Lenstec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-06-30
- Decision date
- 2009-10-27
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- HQC
- Device class
- 2
- Regulation number
- 886.4670
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- St. Petersburg, 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.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
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|---|---|---|
| Softec HD; Softec I; Softec HDO; Softec HDM (P090022/S047) | Lenstec, Inc. | 2025-12-04 |
| ClearView 3 (P200020/S010) | Lenstec, Inc. | 2025-12-04 |
| ClearView 3 Lens (P200020/S009) | Lenstec, Inc. | 2025-08-12 |
| Softec HD; Softec I; Softec HD PS; Softec HDO; Softec HDM (P090022/S046) | Lenstec, Inc. | 2025-08-12 |
| MFK IOL (P200020/S007) | Lenstec, Inc. | 2024-10-11 |
| HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM (P090022/S044) | Lenstec, Inc. | 2024-10-11 |
| THIXO (P200020/S006) | Lenstec, Inc. | 2024-07-11 |
| THIXO-1 Polishing Compound (P090022/S043) | Lenstec, Inc. | 2024-07-11 |