← Product Code [OAP](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP) · K222477 # Hair Growth Device (K222477) _Dongguan Lescolton Medical Equipment Co., Ltd. · OAP · Nov 18, 2022 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K222477 ## Device Facts - **Applicant:** Dongguan Lescolton Medical Equipment Co., Ltd. - **Product Code:** [OAP](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP.md) - **Decision Date:** Nov 18, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5500 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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 have Fitzpatrick Skin Types I to IV. ## Device Story Hair Growth Device (models LS-D620, LS-D630) is a helmet-based system for home use by patients. Device utilizes low-level laser diodes (650-660nm, <5mW) to deliver light to the scalp for hair growth promotion. LS-D620 contains 80 diodes; LS-D630 contains 162 diodes. System includes a protective inner liner and safety limit pads. Operation is battery-powered; device automatically pauses therapy if the head moves outside the radiation zone and resumes upon correct positioning. Audible beeps signal therapy completion. Healthcare providers do not operate the device; patients use it independently. Output is non-ionizing laser radiation; clinical benefit is hair growth stimulation. ## Clinical Evidence Bench testing only. Includes biocompatibility (ISO 10993-5, -10), electrical safety (ANSI AAMI ES60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60825-1). Usability studies conducted with 15 participants per model demonstrated safe and effective use by lay users. ## Technological Characteristics Helmet form factor; ABS housing; silicone/leather contact pads. 80 (LS-D620) or 162 (LS-D630) laser diodes (650-660nm, <5mW). Powered by non-detachable polymer lithium battery. Non-sterile. Home-use environment. Complies with IEC 62133-2 (battery), IEC 60601-1-11 (home healthcare), and IEC 60825-1 (laser safety). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Hair Growth Device ([K210169](/device/K210169.md)) - LG Pra.L Derma LD Scalp Care ([K200464](/device/K200464.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222477 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)
| | | | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ # 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 {4}------------------------------------------------ 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<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system designed to automatically pause to therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern. The Hair Growth Device LS-D620may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 180 minutes. Which meets the requirements of IEC 62133-2 safety standard.. #### 5.2 Device Description for LS-D630: The Hair Growth Device LS-D630 is composed of 162 laser diodes (wavelength: 650-660nm, power<5mW) configured within an outer helmet and protective inner liner. The combined light is absorbed by the scalp. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system designed to automatically pause to therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern. The Hair Growth Device LS-D630 may produce 20% maximum output deviation in different treatment sites. The device uses a non detachable polymer lithium battery for power supply, and the continuous use time for the battery is 80 minutes. Which meets the requirements of IEC 62133-2 safety standard. #### 6. Intended Use of Device 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 have Fitzpatrick Skin Types I to IV. {5}------------------------------------------------ ## 7. Summary of Substantial Equivalence # Table 1 Technical Characteristic in Comparison to Predicate Devices | | Proposed Device | Primary Predicate | Secondary Predicate | Comparison | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k number | K 222477 | K210169 | K200464 | -------- | | Proprietary name | Hair Growth Device | Hair Growth Device | LG Pra.L Derma LD Scalp
Care | -------- | | Model | LS-D620, LS-D630 | LS-D601 | HGN1 | -------- | | Manufacturer | Dongguan Lescolton Medical
Equipment Co., Ltd. | Dongguan Lescolton
Intelligent Electrical
Appliance Co., Ltd. | LG Electronics, Inc. | -------- | | Regulation number | 890.5500 | 890.5500 | 890.5500 | Same | | Regulation name | Infrared Lamp | Infrared Lamp | Infrared Lamp | Same | | Regulatory Class | Class II | Class II | Class II | Same | | Product code | OAP | OAP | OAP | Same | | Common name | Laser, Comb, Hair | Laser, Comb, Hair | Lamp, non-heating, for
promotion of hair growth | Same
The device common name for
Product Code OAP has been
changed to Laser, Comb, Hair | | Review panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic Surgery | Same | | Indications for use | The Hair Growth Device is
indicated to promote hair
growth in males with
androgenetic alopecia who
have Hamilton-Norwood | The Hair Growth Device is
indicated to promote hair
growth in males with
androgenetic alopecia who
have Hamilton-Norwood | The LG Pra.L Derma LD
Scalp Care is indicated to
promote hair growth in males
with androgenetic alopecia
who have Hamilton-Norwood | Same | | | 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 have
Fitzpatrick Skin Types I to IV. | 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. | 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. | | | Intended user | Females & Males | Females & Males | Both sex | Same | | Type of use | OTC | OTC | OTC | Same | | Mode of operation | Low-level laser diodes | Low-level laser diodes and
light emitting diodes | Low-level laser diodes and
light emitting diodes | Substantially equivalent
The Hair Growth Device
LS-D620 is composed of 80 2
class laser diodes.
The Hair Growth Device
LS-D630 is composed of 162
2 class laser diodes. | | Wavelength | Laser: 650-660nm | Laser: 650-660nm
Red light LED: 640-660nm | LD: 650~667nm
LED: 645nm~665nm | Substantially equivalent
The Hair Growth Device
LS-D620 is composed of 80 2
class laser diodes.
The Hair Growth Device
LS-D630 is composed of 162
2 class laser diodes. | | No. of light source | LS-D620 Laser diodes: 80
LS-D630 Laser diodes: 162 | Laser diodes: 26
LED diodes: 30 | 250 | Different¹ | | Power output | <5mW per light output point | <5mW per light output point | 5mW per light output point | Same | | Treatment duration | LS-D620: 20 minutes each
time for 16 weeks
LS-D630: 12 minutes each
time for 16 weeks | 25 minutes each time for 16
weeks | 18 minutes or 27 minutes | Different2 | | Way to get power | Rechargeable battery | Power adapter | Rechargeable battery | Same as K200464 | | Bluetooth | No | No | Yes | Same as K210169 | | Weight | LS-D620: 993g ±2%
LS-D630: 836g ±2% | 625g | 790g | Different3 | | Sterilization
requirements | Non-sterile | Non-sterile | Non-sterile | Same | | Materials | LS-D620,LS-D630
Laser dome housing: ABS | Laser dome housing: ABS | Shell: ABS | Same | | | LS-D620 Light source
contactless safety limit pad :
Silicone Pad/Leather mat. | Light source contactless safety
limit pad:
Silicone Pad | Safety limit pad : Silicone Pad | Different4 | | | LS-D630 Light source
contactless safety limit pad :
Silicone Pad | Light source contactless safety
limit pad:
Silicone Pad | Safety limit pad : Silicone Pad | Same | | Laser window power
value | 4.5wm±10% | 4.5wm±10% | 5wm | Same | | Maximum output
irradiance | LS-D620/ LS-D630 :
40mW/cm² | 40mW/cm² | Don't know | Same as K210169 | {6}------------------------------------------------ # Dongguan Lescolton Medical Equipment Co., Ltd {7}------------------------------------------------ # Dongguan Lescolton Medical Equipment Co., Ltd #### 8. Substantial Equivalence discussion: Note 1: Number of light source of proposed device is more than that of primary predicate K210169. This diffectiveness of proposed device. {8}------------------------------------------------ Note 2: The treatment time of the proposed device is different from the subject predicate k200464. The proposed device has passed the safety and EMC compatibility tests. This difference does not improve the safety and effectiveness of the proposed device. Note 3: The weight of the proposed device is different from the subject predicate has passed the safety test. This difference does not improve the safety and effectiveness of the proposed device. Note 4: The proposed device Ls-D620 light source contactless safety limit pad is different from the subject predicate. The proposed equipment and materials have passed the biocompatibility test. This difference does not improve the safety and effectiveness of the proposed device. Note 5: The proposed device Ls-D620 light source contactless safety limit pad is different from the subject predicate and materials have passed the biocompatibility test. This difference does not improve the safety and effectiveness of the proposed device. Most technical specifications of the Hair Growth Device LS-D620, LS-D630 are either the same or substantially equivalent as compared to the predicate devices. There are no technological differences that raise new or different questions of safety or effectiveness. {9}------------------------------------------------ #### 9. Non-Clinical Tests Performed: The following non-clinical testing was provided in this 510(k): Biocompatibility Testing - The skin contacting materials of the device were subjected to biocompatibility testing per ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" for devices in contact with intact skin, including in vitro cytotoxicity, skin sensitization, and skin irritation. All tests passed. The tests comply with the applicable requirements of the following standards: ISO10993-5:2009, Biological evaluation of medical devices-Part 5: tests for in vitro cytotoxicity. ISO10993-10:2010, Biological evaluation of medical devices-Part10: tests for irritation and skin sensitization. Electrical Safety and Electromagnetic Compatibility Testing -The Hair Growth Device LS-D620, LS-D630 has been tested and complied with the applicable requirements of the following standards for medical devices used in the home environment: · ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance · IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests · IEC 60601-1-11:2015 Medical electrical equipment-Part 1-11: General requirements for basic safety and essential performance - Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment · IEC 60825-1:2007 Safety of laser products - Part 1: Equipment classification, and requirements Software Verification and Validation - Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. #### 10. Usability Study: The Hair Growth Device LS-D620 was performed usability study separately by similar methods. Testing of 15 participants was conducted showing that the participants were able to understand the user manual and box labeling and were able to safely and effectively use the device. The Hair Growth Device LS-D630 was performed usability study separately by similar methods. Testing of 15 participants was conducted showing that the participants were able to understand the user manual and box labeling and were able to safely and effectively use the device. ### 11. Conclusion: The proposed device uses similar or identical technology as the predicate devices and has the same intended use. Based upon the predicted overall performance characteristics for Hair Growth Device LS-D620, LS-D630, Dongguan Lescolton Medical Equipment Co., Ltd., believes that the technological characteristics of Hair Growth Device LS-D620, LS-D630 does not raise new types of questions regarding its safety and efficacy for its intended use compared with the predicate devices. On the basis of the information provided in this 510(k), Dongguan Lescolton Medical Equipment Co., Ltd., Ltd., believes that the Hair Growth Device LS-D620, LS-D630 is substantially equivalent to the predicate devices. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K222477](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94physical-medicine-therapeutic-devices/OAP/K222477) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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