LENSERT CONTACT LENS CLEANING & INSERT
FDA 510(k) clearance K830738 · decided 1983-06-10
Clearance details
- K-number
- K830738
- Device name
- LENSERT CONTACT LENS CLEANING & INSERT
- Applicant
- Jermyn Specialties of California
- Decision
- Substantially Equivalent
- Date received
- 1983-03-08
- Decision date
- 1983-06-10
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- KYE
- Device class
- 1
- Regulation number
- 886.5420
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SOFT CONTACT LENS REMOVER (K872567) | Magnivision, Inc. | 1987-08-10 |
| HARD CONTACT LENS REMOVER. ITEM #289 (K872591) | Magnivision, Inc. | 1987-08-04 |
| CONTACT LENS TWEEZERS (K871130) | S. M. C. Medi-Tech Corp. | 1987-05-12 |
| SUMMIT OPTICS CONTACT LENS REMOVER (K870072) | Dayton Mfg. Co. | 1987-02-12 |
| MARLIN SOFT LENS HANDLER (K850984) | Marlin Industries | 1985-09-10 |
| MARLIN SOFT LENS TWEEZER (K850983) | Marlin Industries | 1985-09-10 |
| DMV ANGLER (K830496) | Dmv Contact Lens Co. | 1983-03-09 |
| REMOVER, SOFT-SERT CONTACT LENS (K782140) | Mcmurray and Pendergost | 1979-02-12 |
| SOFT LENS INSERTER (K780931) | Soft-Sert | 1978-06-28 |
| SOFT LENS REMOVER/INSERTER/MANIPULATOR (K780664) | Dmv Contact Lens Co. | 1978-05-17 |
| CONTACT LENS REMOVER AND INSERTER (K780663) | Dmv Contact Lens Co. | 1978-05-17 |
Recalls involving this device
No recalls on record reference this clearance.