FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
K Number: K253826
·
Decision May 7, 2026
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
13
Applicant Total
3
Review Days
157
Basic Information
- Device Name
- Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI Flex Needle
- K Number
- K253826
- 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
- Galvanize Therapeutics, Inc.
- Date Received
- December 1, 2025
- Decision Date
- May 7, 2026
- Product Code
- OAB
- 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 |
|---|---|---|---|
| OAB | Low Energy Direct Current Thermal Ablation System | FDA class 2 | General, Plastic Surgery |
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