Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)— 510(k) K261253
Substantially EquivalentZiree Co., Ltd.
FDA 510(k) clearance K261253 for Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5), Substantially Equivalent on 2026-06-26. Applicant: Ziree Co., Ltd.. Device class: 2.
Summary
Ziree's Laser Hair Growth Devices are listed in 15 models, HR-H1 through HR-H10 and HR-I1 through HR-I5. They're filed under OAP, hair laser combs, and the record doesn't say how the models differ.
Class II, 21 CFR 890.5500. The General and Plastic Surgery review panel handled it as a Traditional 510(k); the record lists Physical Medicine as the classification panel.
Ziree filed from Changsha, China. Review took 71 calendar days (April 16 to June 26, 2026).
Clearance details
- Applicant
- Ziree 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
- Changsha, CN
Recent devices under product code OAP
view all- 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)
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
Data sourced from openFDA. This site is unofficial and independent of the FDA.