MARLIN SOFT LENS HANDLER
FDA 510(k) clearance K850984 · decided 1985-09-10
Clearance details
- K-number
- K850984
- Device name
- MARLIN SOFT LENS HANDLER
- Applicant
- Marlin Industries
- Decision
- Substantially Equivalent
- Date received
- 1985-03-11
- Decision date
- 1985-09-10
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- KYE
- Device class
- 1
- Regulation number
- 886.5420
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Tarzana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Marlin Industries
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 TWEEZER (K850983) | Marlin Industries | 1985-09-10 |
| LENSERT CONTACT LENS CLEANING & INSERT (K830738) | Jermyn Specialties of California | 1983-06-10 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S012) | Marlin Industries | 1989-11-22 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S011) | Marlin Industries | 1988-05-05 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S010) | Marlin Industries | 1988-02-04 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S009) | Marlin Industries | 1986-06-09 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S008) | Marlin Industries | 1985-12-16 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S007) | Marlin Industries | 1985-10-03 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S006) | Marlin Industries | 1985-05-21 |
| MARLIN SQUEEZE BOTTLE & MARLIN SALT TABLETS (P800038/S005) | Marlin Industries | 1985-05-15 |