DermaScalp Laser Cap

K173846 · Dermascalp, LLC · OAP · Mar 21, 2018 · Physical Medicine

Device Facts

• Record ID: K173846
• Device Name: DermaScalp Laser Cap
• Applicant: Dermascalp, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Mar 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.

Device Story

Hands-free, portable, non-invasive low-level laser therapy (LLLT) device; treats Androgenetic Alopecia; promotes hair growth. Device consists of concave scalp covering containing multiple red laser modules (650 nm wavelength, <5 mW output power per module). Operates via continuous wave (CW) output; delivers distributed laser energy to scalp via bio-stimulation. Intended for home use by patients. User places cap on head for timed treatments. Output is therapeutic red light; no complex data processing or clinical decision support. Benefits include non-invasive hair growth stimulation. Safety profile consistent with Class 3R laser systems.

Clinical Evidence

No clinical efficacy trials were conducted. Evidence includes bench testing for electrical safety (IEC 60601-1, IEC 60601-1-2), laser safety (IEC 60825-1), and home-use safety (IEC 60601-1-11). Biocompatibility testing performed per ISO 10993-1 and ISO 10993-5. A usability study with 116 adult subjects demonstrated a 93% pass rate for self-selection and 99.4% pass rate for user instruction comprehension, supporting Over-the-Counter (OTC) use.

Technological Characteristics

Hands-free, portable LLLT device. Emits 650 nm red laser light via multiple diodes (50-272 count). Output power <5 mW per diode; total output <1,760 mW. Continuous wave (CW) mode. Materials tested per ISO 10993-1 and ISO 10993-5. Class 3R laser system per IEC 60825-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; home-use safety per IEC 60601-1-11.

Indications for Use

Indicated for males (Norwood Hamilton IIa-V) and females (Ludwig/Savin I-1 to I-4, II-1, II-2, or frontal) with Androgenetic Alopecia and Fitzpatrick Skin Types I-IV to promote hair growth.

Regulatory Classification

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

• iGrow II Hair Growth System (K152019)
• Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus312, and Capillus352 (K163170)
• Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 (K161875)

Reference Devices

• DermaScalp Laser Cap (K152587)

Submission Summary (Full Text)

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March 21, 2018

DermaScalp LLC John Carullo Managing Member 190 E. Stacy Rd Suite 306-291 Allen, Texas 75002

Re: K173846

Trade/Device Name: D DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 14, 2017 Received: December 19, 2017

Dear John Carullo:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely. Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K173846

Device Name DermaScalp Laser Cap

Indications for Use (Describe)

The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia and promote hair growth in Males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in Females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with 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)

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## ATTACHMENT 2

# 510(k) SUMMARY

| 510(k) Owner: | DermaScalp LLC<br>190 E. Stacy Rd.<br>Suite 306-291<br>Allen, TX 75002<br>Contact: John Carullo<br>Phone: [phone] | | | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------|-----------------------------|---------------------------------------------------------------------------------------|-----------------|----------|
| Date Summary Prepared: | December 14, 2017 | | | | | | |
| Device: | <table><tr><td>Trade Name:</td><td>DermaScalp Laser Caps</td></tr><tr><td>Common/Classification Name:</td><td>Light Therapy Hair System<br/>Product Code OAP<br/>21 C.F.R. § 890.5500 (Infrared lamp)</td></tr><tr><td>Classification:</td><td>Class II</td></tr></table> | Trade Name: | DermaScalp Laser Caps | Common/Classification Name: | Light Therapy Hair System<br>Product Code OAP<br>21 C.F.R. § 890.5500 (Infrared lamp) | Classification: | Class II |
| Trade Name: | DermaScalp Laser Caps | | | | | | |
| Common/Classification Name: | Light Therapy Hair System<br>Product Code OAP<br>21 C.F.R. § 890.5500 (Infrared lamp) | | | | | | |
| Classification: | Class II | | | | | | |
| Predicate Devices: | iGrow II Hair Growth System - Apira Science Inc - K152019<br>Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus312, and Capillus352 – Capillus LLC – K163170<br>Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 – K161875 | | | | | | |
| Reference Device: | DermaScalp Laser Cap - DermaScalp LLC - K152587 (Previously FDA cleared) | | | | | | |

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| Device<br>Description: | The family of DermaScalp Laser Cap devices are a hands-free, portable, non-<br>invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair<br>Loss) and to promote hair growth in Males and Females. The DermaScalp<br>Laser Cap devices provide distributed red laser light dispersing from a<br>"Concave" scalp covering utilizing laser modules with a 650 nm wavelength,<br><5 mW output power, producing a continuous wave "CW" output beam. The<br>"Concave" scalp covering is designed to maximize the delivery of the coherent<br>laser light to effectively cover the entire scalp of the user during treatment. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The family of DermaScalp Laser Cap devices are indicated to treat<br>Androgenetic Alopecia and promote hair growth in Males who have Norwood<br>Hamilton Classifications of IIa to V patterns of hair loss and to treat<br>Androgenetic Alopecia and promote hair growth in Females who have Ludwig<br>(Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I<br>to IV. |
| Technological<br>Characteristics: | The family of DermaScalp Laser Cap devices are a hands-free portable device<br>that produce red laser energy dispersed from a "Concave" scalp covering as it<br>rests upon a user's head and creates a laser field that covers the users entire<br>scalp area. The devices produce timed treatments of equally distributed laser<br>energy to the full scalp area. The treatment received from the laser energy<br>promotes hair growth in both Males and Females and treats Androgenetic<br>Alopecia (Hair Loss) by the therapeutic modality of bio-stimulation. |
| Biocompatibility<br>Data: | The construction of the family of DermaScalp Laser Cap devices do not raise<br>any biocompatibility issues. All the materials used in the construction of the<br>DermaScalp devices were tested and adhere to the requirements of ISO 10993-<br>1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and<br>Testing within a Risk Management Process, as well as, adhere to the<br>requirements of ISO 10993-5:2009 Biological Evaluation of Medical Devices --<br>Part 5: Tests for in vitro cytotoxicity. |
| Performance<br>Data: | The evaluation of the perfomance data presented confirms that the family of<br>DermaScalp Laser Cap devices have the same or similar Laser Wavelength,<br>Laser Power, Laser Energy Type, Output Mode, Treatment Time, Output<br>Beam, Laser Field Treatment Area, Consumer Usage Focal Length as the FDA<br>Cleared predicate devices.<br><br>Testing to IEC 60601-1 and 60601-1-2 confirm the devices adherence to LVD<br>electrical and EMC safety requirements. Testing to IEC 60825-1 certifies the<br>laser system to classifaction 3R, which is the same as the predicate devices.<br>Testing to IEC 60601-1-11:2015 confirms the basic safety and essential |

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performance of medical electrical equipment and medical electrical systems for use in the home.

DermaScalp used a third party group to to administer a self-selection and usibility study to determine the user comprehension of user instructions, warnings, and precaustions. The testing was administered to 116 adult subjects of any age (>18) of diverse race, age, and educational background. The DermaScalp usibility test demonstrated a pass rate of 93% (self-selection) and 99.4% pass rate for the user instruction questionnaire, satisfying the FDA's requirements for clearance (sale) as Over-the-Counter Intended Use.

Performance Testing is conducted to confirm compliance to design specifications; all functions were verified to operate as designed. The DermaScalp devices met all acceptance criteria in the performance testing.

Substantial The family of DermaScalp Laser Cap devices referenced in this application are Equivalance: the same technology used by the LLLT devices cleared under device code OAP. The DermaScalp Laser Caps are as safe and effective as the predicate devices, as well as other reference devices in its class.

> The sponsor believes that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile. All compliant LLLT systems which use red light diode lasers are classified as class 3R laser systems according to the IEC standard for allowable emission levels, which is a recognized standard by the FDA as well, and the adverse event profile is the same.

| DermaScalp Devices | Capillus Devices | Transdermal Devices | iGrow | OAP Devices (General) |
|-----------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|-----------------------------------------|
| To Be Determined | K163170 | K161875 | K152019 | N/A |
| LLLT Device | LLLT Device | LLLT Device | LLLT Device | LLLT Device |
| OTC | OTC | Prescription | OTC | Prescription and OTC |
| Intended Use-<br>Androgenetic Alopecia | Intended Use-<br>Androgenetic Alopecia | Intended Use-<br>Androgenetic Alopecia | Intended Use-<br>Androgenetic Alopecia | Intended Use-<br>Androgenetic Alopecia |
| Cap Design | Cap Design | Cap Design | Helmet Design | Helmet/Cap, Comb, Brush or Panel Design |
| 650nm | 650nm | 650nm | 655nm | 635-678nm |
| Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females |
| Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free or comb) |

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| Diode Count- 50, 80,<br>120, 148, 180, 202,<br>224, 272 | Diode Count- 82,<br>202, 272, 302, 312,<br>352 | Diode Count- 80,<br>120, 224, 300 | Diode Count- 51 | Diode Count- Ranges<br>from<br>1 to 352 |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------|
| Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP |
| Fitzpatrick Skin<br>Phototypes - I-IV | Fitzpatrick Skin<br>Phototypes - I-IV | Fitzpatrick Skin<br>Phototypes - I-IV | Fitzpatrick Skin<br>Phototypes - I-IV | Fitzpatrick Skin<br>Phototypes - I-IV |
| Ludwig-Savin I-II<br>(females) | Ludwig-Savin I-II<br>(females) | Ludwig-Savin I-II<br>(females) | Ludwig-Savin I-II<br>(females) | Ludwig-Savin I-II<br>(females);<br>Norwood Hamilton<br>IIA-V (males);<br>or both genders |
| Norwood Hamilton IIA-<br>V (males) | Norwood Hamilton<br>IIA-V (males) | Norwood Hamilton<br>IIA-V (males) | Norwood Hamilton<br>IIA-V (males) | |
| Treatment- 17weeks,<br>every other day<br>(indefinite) | Treatment- 17weeks,<br>every other day<br>(indefinite) | Treatment-<br>17weeks, every<br>other day (indefinite) | Treatment-<br>17weeks, every<br>other day<br>(indefinite) | Treatment-<br>approximately<br>17weeks, every<br>other day (indefinite) |
| Total Laser Energy<br>Output: <250mW,<br><400mW, <600mW,<br><740mW, <900mW,<br><1,010mW,<1,120mW,<br><1,360mW | Total Laser Energy<br>Output: <410mW,<br><1,010mW,<br><1,360mW,<br><1,510mW,<br><1,560mW, and<br><1,760mW | Total Laser Energy<br>Output: <400mW,<br><600mW,<br><1,120mW,<br><1,500mW | Total Laser Energy<br>Output: <255mW | Total Laser Energy<br>Output: Ranges from<br><5mW to <1,760mW |
| Device Class II | Device Class II | Device Class II | Device Class II | Device Class II |

For these reasons, the family of DermaScalp Laser Caps satisfy the FDA's substantial equivalence requirements with respect to intended use, technological and design characteristics. With reference to all devices cleared through the OAP device classification, the sponsor respectfully proposes that the FDA has acknowledged that Low-Level Laser/Light Therapy is a viable modality for treating androgenic alopecia in both genders and that the red light lasers in class 3R, used in the DermaScalp devices referenced in this application are substantially equivalent to the predicates. Additionally, no new safety or efficacy concerns are raised due to the minor differences present between devices.

- Conclusions: The family of DermaScalp Laser Cap devices are as safe and effective as the FDA Cleared predicate devices for male and female treatment, and is thefore Substantial Equivalent to the FDA Cleared predicate devices with respect to intended use, technological characteristics and safety characteristics.