FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
SANDRO Dual
K Number: K252877
·
Decision Dec 19, 2025
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
28
Review Days
100
Basic Information
- Device Name
- SANDRO Dual
- K Number
- K252877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wontech Co., Ltd.
- Date Received
- September 10, 2025
- Decision Date
- December 19, 2025
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Wontech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K250165 | Pastelle | Jul 3, 2025 | Substantially Equivalent |
| K251288 | Veincare | May 14, 2025 | Substantially Equivalent |
| K251094 | Alma Veil | May 6, 2025 | Substantially Equivalent |
| K243957 | PICOALEX | Mar 12, 2025 | Substantially Equivalent |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Feb 14, 2025 | Substantially Equivalent |
| K241527 | Pastelle Pro | Feb 14, 2025 | Substantially Equivalent |
| K243929 | Oligio X | Jan 21, 2025 | Substantially Equivalent |
| K241930 | Veincare | Nov 14, 2024 | Substantially Equivalent |
| K241406 | Lavieen | Jun 28, 2024 | Substantially Equivalent |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Jun 24, 2024 | Substantially Equivalent |