Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)— 510(k) K262183
Substantially EquivalentShenzhen Nuon Medical Equipment Co., Ltd.
FDA 510(k) clearance K262183 for Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60), Substantially Equivalent on 2026-09-24. Applicant: Shenzhen Nuon Medical Equipment Co., Ltd.. Device class: 2.
Summary
Shenzhen Nuon Medical Equipment Co., Ltd. cleared eight Hair Growth Helmet models in one file (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, and TK-60). The product code is OAP, named for laser hair combs; these helmets are cleared under the same code.
Class II, 21 CFR 890.5500. The record lists Physical Medicine as the advisory panel and General and Plastic Surgery as the review panel. It was a Traditional 510(k).
Nuon filed from Shenzhen, China. Review took 87 days (June 29 to September 24, 2026). The record doesn't explain how the models differ.
Clearance details
- Applicant
- Shenzhen Nuon Medical Equipment 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- 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)
- 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)
- K261253 — 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)
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
More clearances from Shenzhen Nuon Medical Equipment Co., Ltd.
view all- K251034 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
- K242151 — Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
- K242700 — Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
- K241342 — Hair Growth Comb (SZ-23,SZ-23A)
- K241155 — Cold Sore Device (QPZ-03)
Data sourced from openFDA. This site is unofficial and independent of the FDA.