FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
K Number: K223862
·
Decision Apr 28, 2023
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
109
Applicant Total
28
Review Days
126
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Basic Information
- Device Name
- Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
- K Number
- K223862
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wontech Co., Ltd.
- Date Received
- December 23, 2022
- Decision Date
- April 28, 2023
- Product Code
- OAP
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| OAP | Laser, Comb, Hair | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAP), ordered by most recent decision date.
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Other Clearances by Wontech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252877 | SANDRO Dual | Dec 19, 2025 | Substantially Equivalent |
| K250165 | Pastelle | Jul 3, 2025 | Substantially Equivalent |
| K251288 | Veincare | May 14, 2025 | Substantially Equivalent |
| K251094 | Alma Veil | May 6, 2025 | Substantially Equivalent |
| K243957 | PICOALEX | Mar 12, 2025 | Substantially Equivalent |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Feb 14, 2025 | Substantially Equivalent |
| K241527 | Pastelle Pro | Feb 14, 2025 | Substantially Equivalent |
| K243929 | Oligio X | Jan 21, 2025 | Substantially Equivalent |
| K241930 | Veincare | Nov 14, 2024 | Substantially Equivalent |
| K241406 | Lavieen | Jun 28, 2024 | Substantially Equivalent |