Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
FDA 510(k) clearance K240264 · decided 2024-03-08
Clearance details
- K-number
- K240264
- Device name
- Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)
- Applicant
- Shenzhen Mlay Intelligent Technology Co., , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-31
- Decision date
- 2024-03-08
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- OHT
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, 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.