FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
K Number: K240222
·
Decision Jun 4, 2024
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
2
Review Days
130
Basic Information
- Device Name
- Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)
- K Number
- K240222
- 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
- Aesthetic Technology Ltd
- Date Received
- January 26, 2024
- Decision Date
- June 4, 2024
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
AviClear Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SurgiLight 1470 Diode Laser System (Model:Halo)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AuroLase® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Diode laser device (RF3120-BI)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Aesthetic Technology Ltd
| K Number | Device Name | ||
|---|---|---|---|
| K202028 | dermalux Flex MD | Dec 16, 2020 | Substantially Equivalent |