LG Pra. L Derma LD Scalp Care
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200464 FDA 510(k)
- FDA Product Code
- OAP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LG Pra. L Derma LD Scalp Care is a Class 2 medical device classified under the Laser, Comb, Hair device category. It is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V.
The device is supplied as a single-use item and is cleared through the Traditional 510(k) pathway under FDA regulation 21 CFR 890.5500. It is manufactured by LG Electronics Inc. and is intended for use in physical medicine applications.
Frequently asked questions
What is the LG Pra. L Derma LD Scalp Care used for?
It is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V, as stated in the device description.
How is the LG Pra. L Derma LD Scalp Care supplied and is it reusable?
The device is supplied as a single-use item, meaning it is intended for one-time use and should not be reused, as specified in the description.
What regulatory pathway was used for the LG Pra. L Derma LD Scalp Care?
It was cleared through the Traditional 510(k) pathway under FDA regulation 21 CFR 890.5500, as noted in the device data.
What type of medical device is the LG Pra. L Derma LD Scalp Care classified as?
It is a Class 2 medical device classified under the Laser, Comb, Hair device category, according to the provided description.
Who manufactures the LG Pra. L Derma LD Scalp Care and where is it made?
It is manufactured by LG Electronics Inc., with the manufacturer's address listed as 222, Lg-Ro, Jinwi-Myeon, Pyeongtaek-Si, 17709, South Korea (country code KR).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LG Pra. L Derma LD Scalp Care (K200464) — FDA 510 (k) | Innolitics, K200464 FDA 510 (k) - LG Pra. L Derma LD Scalp Care, fda.innolitics.com, LG Pra. L Derma LD Scalp Care 510(k) K200464 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200464 | Class II | Active |
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Manufacturer
- Manufacturer
- LG Electronics Inc.
- FDA Applicant
- Lg Electronics.Inc
Sources (1)
- FDA 510(k) K200464 24 fields · synced Sep 21, 2026