LASER CANE
FDA 510(k) clearance K903558 · decided 1990-09-27
Clearance details
- K-number
- K903558
- Device name
- LASER CANE
- Applicant
- Nurion Industries
- Decision
- Substantially Equivalent
- Date received
- 1990-08-08
- Decision date
- 1990-09-27
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HPG
- Device class
- 1
- Regulation number
- 886.5900
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Paoli, PA, 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 |
|---|---|---|
| PATHFINDER (K910601) | Nurion Industries | 1991-05-14 |
| LOW VISION ENHANCEMENT SYSTEM (LVES) (K910124) | Triangle Investments | 1991-04-10 |
| POLARON (K902187) | Nurion Industries | 1990-08-08 |
| SENSORY 6 (K862338) | Brytech, Inc. | 1986-09-03 |
| ALES (K823385) | Oms | 1983-03-09 |
| F4912 NIGHT VISION AID (K761215) | Itt Corp. | 1976-12-16 |
Recalls involving this device
No recalls on record reference this clearance.