OPTOVISION Endoscopic Light Source Unit
Optosurgical, LLC · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Columbia
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 6751 Columbia Gateway Dr.
- Address 2
- Suite 300, Office 313
- Statement or summary
- Summary
- Product code
- OWN
- Zip code
- 21046
- Applicant
- Optosurgical, LLC
- Decision date
- 2025-02-19
- Decision code
- SESE
- Country code
- US
- Device name
- OPTOVISION Endoscopic Light Source Unit
- Advisory committee
- GU
- Contact
- Yoseph Kim
- K number
- K243591
- State
- MD
- Date received
- 2024-11-20
- Review advisory committee
- SU
- Postal code
- 21046
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Confocal Optical Imaging
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3006990600, 3010684280, 3012627460, 3014321789, 3018094310, 3007303113, 3013247477, 3004542960, 9610617, 3016555232, 8010047, 3016607092, 3008837339, 3014663814, 3015612252, 3010202439, 3012322232, 3008309062, 2020550, 3010493171, 3009719225, 3013077751, 8043903, 3013868968, 3029968414, 3006973663, 3010707607, 9610773, 3021336392, 3012345110, 3026606306, 9612074, 3015532525, 1220246, 3011063460, 9615010, 3007487007, 3017619652, 3001675293, 3014342096 +28 more
- FEI number
- 3006990600, 3010684280, 3012627460, 3014321789, 3018094310, 3007303113, 3013247477, 3004542960, 3006149253, 3016555232, 3001236549, 3016607092, 3014663814, 3008837339, 3002807798, 3002808273, 3015612252, 3012322232, 3008309062, 2020550, 3006973663, 3010493171, 3009719225, 3007475226, 3002807795, 3013868968, 3013077751, 3029968414, 3010707607, 3021336392, 3012345110, 3026606306, 3015532525, 1220246, 3011063460, 3007487007, 3017619652, 3001675293, 3014342096, 3026753388 +28 more