FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
AGNES Ultra
K Number: K250217
·
Decision Sep 3, 2025
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
7
Review Days
222
Basic Information
- Device Name
- AGNES Ultra
- K Number
- K250217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agnes Medical Co., Ltd.
- Date Received
- January 24, 2025
- Decision Date
- September 3, 2025
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Agnes Medical Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243713 | Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) | Aug 19, 2025 | Substantially Equivalent |
| K242469 | RFMagik Lite | Apr 25, 2025 | Substantially Equivalent |
| K230837 | PlazMagik | Feb 29, 2024 | Substantially Equivalent |
| K223805 | Agnes | May 4, 2023 | Substantially Equivalent |
| K203013 | AGNES | Jul 14, 2022 | Substantially Equivalent |
| K192728 | Agnes | Oct 24, 2019 | Substantially Equivalent |