FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
eCO2 3D
K Number: K244060
·
Decision Jul 31, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
29
Review Days
212
Basic Information
- Device Name
- eCO2 3D
- K Number
- K244060
- 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
- Lutronic Corporation
- Date Received
- December 31, 2024
- Decision Date
- July 31, 2025
- Product Code
- ONG
- 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 |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Lutronic Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251327 | XERF | Aug 11, 2025 | Substantially Equivalent |
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| K213569 | HOLLYWOOD SPECTRA Laser System | Feb 4, 2022 | Substantially Equivalent |
| K203788 | DermaV Laser System | Mar 26, 2021 | Substantially Equivalent |
| K183566 | CLARITY II Laser System | Jun 14, 2019 | Substantially Equivalent |
| K180945 | LUTRONIC GENIUS Radiofrequency System | Dec 10, 2018 | Substantially Equivalent |
| K173700 | PICOPLUS Laser System | Jun 19, 2018 | Substantially Equivalent |
| K171009 | LASEMD Laser System | Jun 23, 2017 | Substantially Equivalent |
| K163196 | ACTION II Laser System | May 24, 2017 | Substantially Equivalent |
| K153769 | R:GEN Laser System | Oct 5, 2016 | Substantially Equivalent |