Alma TED+ System
FDA 510(k) K251684 · Alma Lasers, Inc.
510(k) numberK251684
Submission
- Device name
- Alma TED+ System
- Applicant
- Alma Lasers, Inc.
Buffalo Grove, IL, US - Received
- June 2, 2025
- Decision date
- June 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OAP – Laser, Comb, Hair
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
Other 510(k)s with product code OAP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261675 | CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120…OAP · Traditional | Shenzhen Chuanghong Zhilian Technology Co., Ltd. | 07/17/2026SE |
| K261253 | Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8…OAP · Traditional | Ziree Co., Ltd. | 06/26/2026SE |
| K260899 | Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157…OAP · Traditional | Zdeer Technology (Henan) Co., Ltd. | 06/16/2026SE |
| K253231 | Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser…OAP · Traditional | Hubei Yjt Technology Co.,Ltd | 06/16/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 01/23/2026SE |
| K253349 | Hair Regrowth Cap (Model: T-119-HRC)OAP · Traditional | Light Tree Ventures Europe B.V. | 12/24/2025SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 10/30/2025SE |
| K252325 | Hair Growth Laser CapOAP · Traditional | Cosmo Far East Technology Limited | 10/22/2025SE |
| K251017 | CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)OAP · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 06/17/2025SE |
| K250467 | Red Light Hair Growth Cap (LP-RJVGRW-BLK)OAP · Traditional | Shenzhen Idea Light Limited | 06/05/2025SE |
More from Shenzhen Idea Light Limited
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|---|---|---|
| K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX · Traditional | 09/24/2025SE |
| K251230 | The Alma Hybrid Laser SystemGEX · Special | 05/21/2025SE |
| K243044 | Alma HarmonyGEX · Traditional | 04/11/2025SE |
| K233024 | Alma HarmonyGEX · Traditional | 02/08/2024SE |
| K230308 | Alma HarmonyGEX · Traditional | 03/01/2023SE |
| K230371 | The Alma Soprano TitaniumGEX · Special | 02/22/2023SE |
| K222064 | The Alma Soprano TitaniumGEX · Traditional | 10/12/2022SE |
| K212073 | Alma Diode Tabletop LaserGEX · Traditional | 07/14/2022SE |
| K201520 | The Alma Opus System, Colibri Applicator and TipsGEI · Traditional | 10/27/2021SE |
| K203441 | The Alma Hybrid Laser SystemGEX · Traditional | 07/02/2021SE |
Questions and answers
When was Alma TED+ System cleared by the FDA?
Alma TED+ System (K251684) received a 510(k) decision of Substantially Equivalent on June 5, 2026, 368 days after the submission was received.
What is the product code of K251684?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.