510(k) K231321
K231321 is an FDA 510(k) premarket notification submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. for the device "Nooance Led And Laser Helmet". The FDA issued a decision of Substantially Equivalent on Jul 31, 2023. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Shenzhen Kaiyan Medical Equipment Co., Ltd. has 23 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 31, 2023
- Date Received
- May 8, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
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