LG Pra. L Derma LD Scalp Care
FDA 510(k) K200464 · Lg Electronics.Inc
510(k) numberK200464
Submission
- Device name
- LG Pra. L Derma LD Scalp Care
- Applicant
- Lg Electronics.Inc
Pyeongtaek-Si, KR - Received
- February 26, 2020
- Decision date
- July 23, 2020
- 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
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| 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 |
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| K251684 | Alma TED+ SystemOAP · Traditional | Alma Lasers, Inc. | 06/05/2026SE |
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| 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 |
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| K240130 | Medical Monitor (21HQ613D)PGY · Special | 02/15/2024SE |
| K232985 | 24HR513CPGY · Traditional | 12/11/2023SE |
| K232127 | 21HQ513D, 32HL512D, 31HN713D, 32HQ713DPGY · Special | 08/15/2023SE |
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Questions and answers
When was LG Pra. L Derma LD Scalp Care cleared by the FDA?
LG Pra. L Derma LD Scalp Care (K200464) received a 510(k) decision of Substantially Equivalent on July 23, 2020, 148 days after the submission was received.
What is the product code of K200464?
The FDA product code is OAP – Laser, Comb, Hair, a Class II (moderate risk) device regulated under 21 CFR 890.5500.