DermaScalp Laser Cap

K152587 · Dermascalp, LLC · OAP · Feb 4, 2016 · Physical Medicine

Device Facts

• Record ID: K152587
• Device Name: DermaScalp Laser Cap
• Applicant: Dermascalp, LLC
• Product Code: OAP · Physical Medicine
• Decision Date: Feb 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.

Device Story

DermaScalp MD and MDX Laser Caps are hands-free, portable, non-invasive low-level laser devices; intended to treat Androgenetic Alopecia and promote hair growth in females. Device consists of a concave scalp covering containing an array of red laser diodes (650 nm wavelength, <5 mW per diode, continuous wave output). User wears the cap for 30-minute sessions; device delivers distributed coherent laser light to the entire scalp via bio-stimulation. Device is intended for prescription use. Performance is verified through bench testing against electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and laser safety (IEC 60825-1) standards. Clinical benefit is derived from therapeutic bio-stimulation of hair follicles.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1 Class 3R). Performance testing verified that the device meets design specifications and operates identically to the predicate devices regarding laser wavelength, power, energy type, and treatment parameters.

Technological Characteristics

Hands-free, portable concave scalp covering; 650 nm red laser diodes; continuous wave output; <5 mW per diode; 80 diodes (MD model) or 224 diodes (MDX model); bio-stimulation modality; ISO 10993-1:2009 compliant materials; IEC 60601-1/60601-1-2 electrical/EMC safety; IEC 60825-1 Class 3R laser classification.

Indications for Use

Indicated for females with Androgenetic Alopecia, Ludwig-Savin Classifications I-II, 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

• LaserCap Elite - Transdermal Cap Inc (K150613)
• LaserCap PRO - Transdermal Cap Inc (K150613)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 4, 2016

Dermascalp LLC Mr. John Carullo Managing Member 1700 Alma Drive Suite 400 Plano, Texas 75075

Re: K152587

Trade/Device Name: DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 20, 2015 Received: January 4, 2016

Dear Mr. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Jennifer R. Stevenson -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K152587

### Device Name

DermaScalp Laser Cap Models: DermaScalp MD Laser Cap & DermaScalp MDX Laser Cap

#### Indications for Use (Describe)

The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who 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)

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### ATTACHMENT 2

# 510(k) SUMMARY

| 510(k) Owner: | DermaScalp LLC<br>1700 Alma Dr. Suite 400<br>Plano, TX 75075<br>Contact: John Carullo<br>Phone: [phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | Sebtember 04, 2015 |
| Device: | |
| | Trade Name: DermaScalp Laser Cap |
| | Common/Classification Name: Light Therapy Hair System<br>Product Code OAP |
| | 21 C.F.R. § 890.5500 (Infrared lamp) |
| | Classification: Class II |
| Predicate Devices: | LaserCap Elite - Transdermal Cap Inc - K150613<br>LaserCap PRO - Transdermal Cap Inc - K150613 |
| Device Description: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices<br>are a hands-free, portable, non-invasive, low-level laser device intended to<br>treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in<br>Females. The DermaScalp Laser Cap devices provide distributed red laser<br>light dispersing from a "Concave" scalp covering utilizing laser modules with<br>a 650 nm wavelength, <5 mW output power, producing a continuous wave<br>"CW" output beam. The "Concave" scalp covering is designed to maximize<br>the delivery of the coherent laser light to effectively cover the entire scalp of<br>the user during treatment. |

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| Intended Use: | The DermaScalp Laser Cap is indicated to promote hair growth in females with<br>Androgenetic Alpopecia who have Ludwig (Savin) Classifications I-II and<br>who have Fitzpatrick Skin Types I to IV. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices<br>are a hands-free portable device that produce red laser energy dispersed from a<br>"Concave" scalp covering as it rests upon a user's head and creates a laser field<br>that covers the users entire scalp area. The devices produce timed treatments of<br>equally distributed laser energy to the full scalp area. The treatment received<br>from the laser energy promotes hair growth in Females and treats Androgenetic<br>Alopecia (Hair Loss) by the therapeutic modality of bio-stimulation. |
| Biocompatibility<br>Data: | The construction of the DermaScalp MD Laser Cap and the DermaScalp MDX<br>Laser Cap devices do not raise any biocompatibility issues. All the materials<br>used in the construction of the DermaScalp devices adhere to the requirements<br>of ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1:<br>Evaluation and Testing within a Risk Management Process. |
| Performance<br>Data: | The evaluation of the perfomance data presented confirms that the DermaScalp<br>MD Laser Cap and the DermaScalp MDX Laser Cap devices have the same or<br>similar Laser Wavelength, Laser Power, Laser Energy Type, Output Mode,<br>Treatment Time, Output Beam, Laser Field Treatment Area, Consumer Usage<br>Focal Length as the FDA Cleared predicate devices.<br><br>Testing to IEC 60601-1 and 60601-1-2 confirm the devices adherence to LVD<br>electrical and EMC safely requirements. Testing to IEC 60825-1 certifies the<br>laser system to classifaction 3R, which is the same as the predicate devices.<br><br>Performance Testing is conducted to confirm compliance to design<br>specifications; all functions were verified to operate as designed. The<br>DermaScalp devices met all acceptance criteria in the performance testing. |
| Conclusions: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices<br>are as safe and effective as the FDA Cleared predicate devices for female<br>treatment and is thefore Substantial Equivalent to the FDA Cleared predicate<br>devices with respect to intended use, technological characteristics and safety<br>characteristics. |

### Substantial Equivalence Comparison Table

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| | New Device | Predicate Device |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K152587 | K150613 |
| Company | DermaScalp LLC | Transdermal Inc |
| Name | DermaScalp MD Laser Cap | LaserCap Elite |
| Indications for Use | The DermaScalp MD Laser Cap is indicated<br>to treat Androgenetic Alpopecia and to<br>promote hair growth in Females who have<br>Ludwig (Savin) I-II patterns of hair loss and<br>who have a Fitzpatrick Skin Types I to IV. | LaserCap Elite is indicated to treat<br>Androgenetic Alopecia and to promote hair<br>growth in Females who have Ludwig<br>(Savin) Hair Loss Classification of I to II,<br>and who have a Fitzpatrick Skin Type of<br>I to IV. |
| Indicated Use On | Females | Females |
| Cleared Use for | Prescription Use | Prescription Use |
| Device Type | Scalp Covering Device | Scalp Covering Device |
| Laser Assembly | Red Laser Diodes mounted within a<br>"Concave" scalp covering | Red Laser Diodes mounted within a<br>"Concave" scalp covering |
| Wavelength | 650nm | 650nm |
| Output Beam | Continous Wave "CW" | Continous Wave "CW" |
| Laser Diode Power (each) | <5mW Per IEC 60825-1 ED. 3.0 B:2014 | <5mW Per IEC 60825-1 ED. 3.0 B:2014 |
| Number of Laser<br>Diodes/Optics | Eighty (80) for Females | Eighty (80) for Females |
| Total Laser Energy Output | <400mW for Female use | <400mW for Female use |
| Light Energy Type | Coherent Laser | Coherent Laser |
| Laser Field | Entire Scalp Area | Entire Scalp Area |
| Laser Diode Array | Linear Rows within a<br>"Concave" scalp covering | Linear Rows within a<br>"Concave" scalp covering |
| Total Treatment Time | 30 minutes | 30 minutes |
| Device Application | Portable | Portable |
| Consumer Usage<br>Focal Length | 0.5" - 1.5" from Emanating Diode Location | 0.5" - 1.5" from Emanating Diode Location |
| Ambient Operating<br>Temperature | 50° to 86°F (10° to 30°C) | 32° to 104°F (0° to 40°C) |
| Safety | CE Mark | CE Mark |
| User Manual | Yes | Yes |

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| Substantial Equivalence Comparison Table | | |
|------------------------------------------|--|--|
|------------------------------------------|--|--|

| | New Device | Predicate Device |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K152587 | K150613 |
| Company | DermaScalp LLC | Transdermal Inc |
| Name | DermaScalp MDX Laser Cap | LaserCap PRO |
| Indications for Use | The DermaScalp MDX Laser Cap is<br>indicated to treat Androgenetic Alpopecia<br>and promote hair growth in Females who<br>have Ludwig (Savin) Hair Loss<br>Classification of I-II patterns of hair loss<br>and Fitzpatrick Skin Types I to IV. | LaserCap PRO is indicated to treat<br>Androgenetic Alopecia and promote hair<br>growth in Females who have Ludwig<br>(Savin) Hair Loss Classification of I to II,<br>and who have been determined to have a<br>Fitzpatrick Skin Type of I to IV. |
| Indicated Use On | Females | Females |
| Cleared Use for | Prescription Use | Prescription Use |
| Device Type | Scalp Covering Device | Scalp Covering Device |
| Laser Assembly | Red Laser Diodes mounted within a<br>"Concave" scalp covering | Red Laser Diodes mounted within a<br>"Concave" scalp covering |
| Wavelength | 650nm | 650nm |
| Output Beam | Continous Wave "CW" | Continous Wave "CW" |
| Laser Diode Power (each) | <5mW Per IEC 60825-1 ED. 3.0 B:2014 | <5mW Per IEC 60825-1 ED. 3.0 B:2014 |
| Number of Laser<br>Diodes/Optics | Two hundred twenty-four (224)<br>for Females | Two hundred twenty-four (224)<br>for Females |
| Total Laser Energy Output | <1.120mW for Female use | <1,120mW for Female use |
| Light Energy Type | Coherent Laser | Coherent Laser |
| Laser Field | Entire Scalp Area | Entire Scalp Area |
| Laser Diode Array | Linear Rows within a<br>"Concave" scalp covering | Linear Rows within a<br>"Concave" scalp covering |
| Total Treatment Time | 30 minutes | 30 minutes |
| Device Application | Portable | Portable |
| Consumer Usage<br>Focal Length | 0.5" - 1.5" from Emanating Diode Location | 0.5" - 1.5" from Emanating Diode Location |
| Ambient Operating<br>Temperature | 50° to 86°F (10° to 30°C) | 32° to 104°F (0° to 40°C) |
| Safety | CE Mark | CE Mark |
| User Manual | Yes | Yes |

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