Breo Laser Hair Growth Comb (Scalp 3L)— 510(k) K242620
Substantially EquivalentShenzhen Breo Technology Co., Ltd.
FDA 510(k) clearance K242620 for Breo Laser Hair Growth Comb (Scalp 3L), Substantially Equivalent on 2024-11-01. Applicant: Shenzhen Breo Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen Breo Technology Co., Ltd.
- Product code
- Product code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code OAP
view all- K263313 — Red Light Therapy Hair Growth Cap (RB-009, RB-011, RB-012, RB-088, RB-089, RB-092)
- K262834 — Led and Laser Hair Growth Device (H5520, H5521, H5522, H5523, H5524, H5525, H5530, H5605, H5610, H5615, H5620, H5625, H5630, H6510, H6520, INIA-HM100, ID-FLH-500)
- K262183 — Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)
- K262254 — Hair Growth Comb (X-GC01)
- K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
Data sourced from openFDA. This site is unofficial and independent of the FDA.