WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Wontech Co., Ltd. · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Daejeon
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 64 Techno-8ro, Yuseong-Gu
- Statement or summary
- Summary
- Product code
- GEX
- Zip code
- 34028
- Applicant
- Wontech Co., Ltd.
- Decision date
- 2025-02-14
- Decision code
- SESE
- Country code
- KR
- Device name
- WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
- Advisory committee
- SU
- Contact
- Hyun Sik Yoon
- K number
- K241643
- Date received
- 2024-06-07
- Review advisory committee
- SU
- Postal code
- 34028
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Powered Laser Surgical Instrument
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4810
- Device class
- 2
- Registration number
- 3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 3007156625, 1000523114, 3002806603, 3012294783, 3007535734, 2031934, 3033126947, 3019252665, 2521877, 1226005, 3004497289, 3006985163, 3003610527, 3030979014, 9710340, 1424785, 3026400760, 3004111573, 3006786907, 3044175602, 2032092, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436 +453 more
- FEI number
- 3017144492, 3038356864, 3016096097, 3017786046, 3043153468, 1000623228, 1000523114, 3002806603, 3012294783, 3007535734, 3033126947, 3019252665, 2521877, 3004497289, 3006985163, 3003610527, 3030979014, 3026400760, 3003559308, 3004111573, 3006786907, 3044175602, 3016830208, 3010822033, 2027755, 3003288808, 3011050570, 3016170453, 3014577013, 3005282635, 3027605646, 3016413636, 3042261306, 3008085016, 3006580954, 3010363436, 3001362763, 2938889, 3042953831, 3004361445 +451 more