Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
FDA 510(k) clearance K253231 · decided 2026-06-16
Clearance details
- K-number
- K253231
- Device name
- Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
- Applicant
- Hubei Yjt Technology Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-16
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- OAP
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Wuhan, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.