VS3-IR system
510(k) K152204
VS3-IR system is a medical device (FDA Class II; FDA product code OWN, Confocal Optical Imaging) made by Visionsense Ltd., cleared under FDA 510(k) K152204 on 28 Oct 2015, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152204 | Date28 Oct 2015 | StatusActive |
Official records
- FDA 510(k) database K152204
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWN
- FDA applicant
- Visionsense, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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