LOBOB UNIVERSAL CONTACT LENS CLEANER
FDA 510(k) clearance K990044 · decided 1999-02-11
Clearance details
- K-number
- K990044
- Device name
- LOBOB UNIVERSAL CONTACT LENS CLEANER
- Applicant
- Lobob Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-06
- Decision date
- 1999-02-11
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LPN
- Device class
- 2
- Regulation number
- 886.5928
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Washington, DC, 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
| Record | Firm | Date |
|---|---|---|
| SOF PRO-CLEAN CONTACT LENS CLEANER (P810041/S007) | Lobob Laboratories, Inc. | 1990-09-13 |
| SOF PRO-CLEAN CONTACT LENS CLEANER (P810041/S006) | Lobob Laboratories, Inc. | 1988-03-16 |
| SOF!PRO-CLEAN CONTACT LENS CLEANER (P810041/S004) | Lobob Laboratories, Inc. | 1986-07-07 |
| SOF PRO-CLEAN CONTACT LENS CLEANER (P810041/S005) | Lobob Laboratories, Inc. | 1986-06-24 |
| SOF!PRO-CLEAN CONTACT LENS CLEANER (P810041/S003) | Lobob Laboratories, Inc. | 1984-06-04 |
| SOF!PRO-CLEAN CONTACT LENS CLEANER (P810041/S001) | Lobob Laboratories, Inc. | 1982-08-20 |