The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.

Device Description

The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these specific number 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 will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is reestablished. This is achieved by a safety interlock. At the beginning and end of a therapy session, audible tones are delivered to the user, indicating that therapy has begun (2 beeps) or ended (one long beep). The system is powered by rechargeable Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells pack and charger are fully compliant to recognized, international standards.

AI/ML Overview

This document describes a 510(k) premarket notification for the LaserCap LCPro and LCElite devices. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable as they relate to clinical studies that were not performed or submitted for this 510(k).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria or specific performance metrics (e.g., hair growth percentage, hair count increase) from a clinical study. Instead, it relies on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

However, it does state an Intended Use / Indications for Use:
"The LCPro and LCElite are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV."

Device Characteristics provided:

Device	Number of Lasers	Emission Type	Wavelength
LCPro	224	pulsed-emission	650 nanometers
LCElite	80	continuous-emission	650 nanometers

The performance data states: "No Clinical trial data for LCPro and LCElite were submitted for this 510(k)."

2. Sample size used for the test set and the data provenance: Not applicable – No clinical trial data was submitted or referenced as a test set for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable – No clinical trial data was submitted or referenced, so no ground truth establishment by experts is detailed for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable – No clinical trial data was submitted or referenced, so no adjudication method for a test set is detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable – This device is a low-level laser therapy device for hair growth, not an AI-assisted diagnostic or therapeutic device for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable – This device does not involve an algorithm or AI for standalone performance evaluation in the context described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable – No clinical trial data requiring ground truth for performance evaluation was submitted.

8. The sample size for the training set: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

9. How the ground truth for the training set was established: Not applicable – No clinical trial data or algorithm requiring a training set was part of this 510(k) submission.

Summary of the document's approach to "proving" the device meets criteria:

Instead of a clinical study demonstrating acceptance criteria, the 510(k) application for the LaserCap LCPro and LCElite relies on the concept of substantial equivalence to legally marketed predicate devices.

The document indicates the following about how the device "meets acceptance criteria" (in the context of substantial equivalence):

Technological Characteristics: The LCPro and LCElite utilize similar technological characteristics (red light diode lasers, 650 nm wavelength) to the predicate devices (Capillus272 Pro and Theradome LH 80 Pro). The LCPro uses pulsed emission similar to Capillus272 Pro, and the LCElite uses continuous emission similar to Theradome LH 80 Pro.
Energy and Irradiance Output: The devices provide "similar energy and irradiance output to the treatment area" as their respective predicates.
Intended Use: The intended use of promoting hair growth in females with androgenetic alopecia (Ludwig-Savin Classifications I-II, Fitzpatrick Skin Phototypes I-IV) is the same as the predicate devices.
Safety and Effectiveness: The sponsor believes that "the differences between the subject devices of this 510(k) compared with the predicate devices, do not substantially affect the therapeutic value or the safety profile."
Standards Conformance: The devices were tested for conformance with several international standards: IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133. This demonstrates basic electrical safety and electromagnetic compatibility compliance, which are general controls for medical devices.

In essence, the "proof" for this 510(k) is the demonstration that these new devices are sufficiently similar to already cleared devices that they are considered substantially equivalent, implying they carry the same level of safety and effectiveness as the predicates without the need for new clinical data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.

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

Transdermal Cap Incorporated % Mr. Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928

July 22, 2015

Re: K150613

Trade/Device Name: LaserCap LCPro and LCElite Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: June 17, 2015 Received: June 19, 2015

Dear Mr. Blanche:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

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 (800) 638-2041 or (301) 796-7100 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" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerelv vours.

Joshua C. Nipper -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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K150613

Device Name LaserCap LCPro and LCElite

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Export under an IDP with a DE1191 Statement. Please see instructions.	☐ This is a one-time-only Export.
-------------------------------------------------------------------------	-----------------------------------

X | 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."

{3}------------------------------------------------

510(k) Summary

Transdermal Cap, Inc.

Submitter's Contact Information

Name:	Raymond R. Blanche
Address	NST Consulting, LLC641 Shunpike Road, Suite 311Chatham, NJ 07928
Telephone:Facsimile:	(973) 539-7444(973) 539-7445

Name of Device and Name/Address of Sponsor

Trade Name:	Lasercap, LCPro and LCElite
Sponsor ContactInformation:	Michael Rabin, MDTransdermal Cap, Inc.3615 Superior Avenue, Suite 3104FCleveland, Ohio 44114T. 877-711-4769F. 860-201-1846
Common or Usual Name:	Lamp, non-heating, for promotion of hair growth
Classification Name:	Infrared lamp per 21 CFR 890.5500

Classification Code: OAP (Laser, comb, hair)

Predicate Devices:

Device Trade Name	Manufacturer
Capillus272 Pro – K143199	Capillus, LLC
Theradome LH 80 Pro – K113097	Theradome, Inc.
Reference Devices:
Hairmax Lasercomb - K142573	Lexington Inter

Date Prepared: July 16, 2015 Revised 。
『

rnational

{4}------------------------------------------------

Intended Use / Indications for Use

The LCPro and LCElite are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV.

Technological Characteristics

{5}------------------------------------------------

Performance Data:

No Clinical trial data for LCPro and LCElite were submitted for this 510(k). The LCPro and LCElite were tested for standards conformance with IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133.

Substantial Equivalence

The LCPro and LCElite utilize the same technological characteristics as the predicate devices. The LCPro uses the same pulsing characteristics for its laser diodes as the K143199 (Capillus272 Pro) device, and provides similar energy and irradiance output to the treatment area as this predicate. The LCElite uses continuous-output laser diodes as the K113097 (Theradome LH80 Pro) device does, and provides similar energy and irradiance output to the treatment area as this predicate The LCPro contains 224 lasers and the LCElite contains 80. The target audience of these devices is the same. The two offerings are presented to offer the prescribing physician an economic alternative for his patients.

The LCPro and LCElite are designed to provide low-level-laser therapy. Both predicate devices and the proposed devices use red light diode lasers. The sponsor believes that the differences between the subject devices of this 510(k) compared with the predicate devices, do not substantially affect the therapeutic value or the safety profile. There are differences in the physical appearances of the LCPro and LCElite, compared to the predicates.

Conclusion

The LCPro and LCElite utilize the same technological characteristics as the predicate devices listed above, and are to be used for the same intended use. The sponsor believes that there are no new types of safety and effectiveness questions for the LCPro and LCElite when compared with

{6}------------------------------------------------

the predicate devices, and therefore that the devices should be considered substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.