FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
K Number: K241144
·
Decision Jun 24, 2024
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
11
Review Days
60
Basic Information
- Device Name
- Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K Number
- K241144
- 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
- Won Tech Co., Ltd.
- Date Received
- April 25, 2024
- Decision Date
- June 24, 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 Won Tech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251094 | Alma Veil | May 6, 2025 | Substantially Equivalent |
| K241406 | Lavieen | Jun 28, 2024 | Substantially Equivalent |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Mar 15, 2024 | Substantially Equivalent |
| K240313 | Oligio X | Feb 22, 2024 | Substantially Equivalent |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Feb 7, 2024 | Substantially Equivalent |
| K223727 | Lavieen | Aug 25, 2023 | Substantially Equivalent |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Apr 28, 2023 | Substantially Equivalent |
| K212127 | Picocaremajesty | Jan 7, 2022 | Substantially Equivalent |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Sep 30, 2019 | Substantially Equivalent |
| K183563 | Holinwon 30 | Sep 5, 2019 | Substantially Equivalent |