(94 days)
Not Found
No
The description focuses on the physical components (laser diodes, helmet) and basic automated functions (pausing/resuming therapy based on head position, audible beep). There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is indicated to "promote hair growth" for specific conditions (androgenetic alopecia) and its description includes terms like "therapy cycle" and design features to ensure effective "therapy," indicating a treatment purpose.
No
The device is indicated to "promote hair growth" and describes the physical components of the device and how it delivers light to the scalp for therapeutic purposes, rather than to diagnose a condition.
No
The device description explicitly details hardware components including laser diodes, a helmet, a protective inner liner, and a battery. It also describes physical functions like pausing therapy based on head position and emitting an audible beep.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hair Growth Device described uses laser light applied externally to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use is to promote hair growth, not to diagnose or monitor a condition through the analysis of biological specimens.
The information provided clearly indicates that this is a therapeutic device that applies energy to the body, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. All users should also have Fitzpatrick Skin Types I to IV.
Product codes
OAP
Device Description
The Hair Growth Device LS-D620 is composed of 80 laser diodes (wavelength: 650-660nm, power
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2022
Dongguan Lescolton Medical Equipment Co., Ltd % Shanfeng Jiang Quality Manager Guangzhou Junvi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, Guangdong 510663 China
Re: K222477
Trade/Device Name: Hair Growth Device Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: August 16, 2022 Received: August 16, 2022
Dear Shanfeng Jiang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Hair Growth Device
Indications for Use (Describe)
The Hair Growth Device is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV. All users should also have Fitzpatrick Skin Types I to IV.
| Type of Use (Select one or both, as applicable) | |||||
|---|---|---|---|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) ☒ Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) | ☒ Over-The-Counter Use (21 CFR 801 Subpart C) | ||
| Prescription Use (Part 21 CFR 801 Subpart D) | |||||
| ☒ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - 510(k) Summary
K222477
Date of Summary Preparation: July 16, 2022 Date of Modification: September 04, 2022 Date of Modification: October 01, 2022 Date of Modification: October 26, 2022
1. Submitter's Identifications
Submitter's Name: Dongguan Lescolton Medical Equipment Co., Ltd. Address: 402, Building 1, # 3, Xinxing 3rd Road, jiaoshe, Dongkeng Town, Dongguan City, Guangdong Province, China ZIP Code: 523443 Contact Person: QIxiang Liu Contact Title: General Manager Contact E-mail Address: liuqixiang@lescolton.com Telephone: +86-769-81013189
2. Correspondent's Identifications
Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Shanfeng Jiang Contact Title: Regulation Control Manager Contact E-mail Address: jiang13620586569@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
3. Name of the Device
Trade Name: Hair Growth Device Model: LS-D620, LS-D630 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Common Name: Laser, Comb, Hair Regulatory Class: Class II Product Code: OAP Review Panel: General & Plastic Surgery
4. The Predicate Devices
Primary Predicate: K210169 Hair Growth Device
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Secondary Predicate: K200464 LG Pra.L Derma LD Scalp Care
5. Device Description
5.1 Device Description for LS-D620:
The Hair Growth Device LS-D620 is composed of 80 laser diodes (wavelength:
650-660nm, power