LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopeda who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of lla-V and for both, Fitzpatrick Skin Phototypes I to IV.

Device Description

LaserCap300, LaserCap224, LaserCap120, and LaserCap80 consist of red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner liner, and configured for portable use with rechargeable battery and adapter. The devices only vary in number of lasers (300, 224, 120, and 80 diodes, respectively) and LaserCap300 has a small extension of the LaserCap housing perimeter where its additional laser diodes target peripheral hair-bearing areas of the scalp. As stated in prior submissions, the devices emit an audible tone at the beginning and end of a therapy session, indicating that therapy has begun (1 short beep) or ended (one long beep). The portable systems are powered by rechargeable Li-lon battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.

AI/ML Overview

The provided text describes the regulatory filing for the "LaserCap" family of devices (LaserCap300, LaserCap224, LaserCap120, LaserCap80) for promoting hair growth. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study to prove new acceptance criteria.

Therefore, the information you requested about acceptance criteria met by a specific study is not directly available in the provided text as the application relies on proving similarity to already approved devices.

However, I can extract information related to the device's performance based on the substantial equivalence argument, which implies that the device meets the same safety and effectiveness standards as the predicate devices.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating sameness to predicate devices that have already met regulatory standards. The reported device performance is therefore described in terms of its technological characteristics matching, or being acceptably similar to, predicate devices.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (LaserCap Family)
Safety:
Laser Classification (e.g., 3R)	Conforms to IEC 60825-1, Class 3R
Accessible Emission Limits (AEL)	< 5 milliwatts maximum
Electrical Safety (Electromagnetic Compatibility, Basic Safety)	Conforms to IEC 60601-1-11, IEC 60601-1-2
Battery Safety	Conforms to IEC 62133
Biocompatibility of Skin-Contact Materials	Same biocompatible materials as predicates
Adverse Events Profile	No reported adverse events (for this technology in general)
Effectiveness (Implied by Predicate Equivalence):
Promotion of Hair Growth (Indications for Use)	Intended for promotion of hair growth
Target Population (Gender, Alopecia Classification, Skin Phototype)	Females: Ludwig-Savin I-II; Males: Hamilton-Norwood IIa-V; Fitzpatrick Skin Phototypes I-IV
Wavelength	650nm (matches predicates)
Laser Diode Power	<5mW (matches predicates)
Treatment Frequency	17 weeks, every other day (indefinite) (matches predicates)
Hands-free Use	Yes (matches predicates)

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific clinical "test set" used for the LaserCap devices to demonstrate new clinical efficacy or safety. The argument is based on substantial equivalence to existing predicate devices.
The data provenance mentioned relates to the standards the devices conform to (e.g., IEC standards accepted by the FDA) and the history of no reported adverse events for this technology generally.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The document does not describe a clinical study with a "test set" requiring experts to establish ground truth for the new LaserCap devices. The ground truth for the predicate devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set described for the LaserCap devices.

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 (LLLT) device, not an AI or imaging device that would typically involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a medical device for therapy, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the LaserCap devices is implicitly that they are equivalent to the predicate devices and thus promote hair growth and are safe, aligning with existing clinical evidence for LLLT for androgenetic alopecia.
For the predicate devices, the original ground truth would have been based on clinical studies demonstrating efficacy (e.g., hair count, global photographic assessment) and safety outcomes for hair growth promotion in the specified populations.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a "training set" for an algorithm. The "training" for the substantial equivalence argument relies on the existing body of evidence and regulatory approvals for LLLT devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set described.

In summary, the provided document is a 510(k) summary for medical device clearance based on substantial equivalence. It argues that the LaserCap devices are as safe and effective as already legally marketed predicate devices, and therefore do not require new, extensive clinical studies to establish their own acceptance criteria or separate clinical ground truth.

Summary

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Public Health Service

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

September 30, 2016

Transdermal Cap, Inc. Michael Rabin CEO 938 Chestnut Run Gates Mills, Ohio 44040

Re: K161875

Trade/Device Name: Lasercap300, Lasercap224, Lasercap120, Lasercap80 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: July 6, 2016 Received: July 8, 2016

Dear Michael Rabin:

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

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related adverse events) (21 CFR Part 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 Parts 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Christopher J. Ronk -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) K161875

Device Name

LaserCap300, LaserCap224, LaserCap120, LaserCap80

Indications for Use (Describe)

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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510 (k) Summary

Transdermal Cap, Inc.

Submitter and Sponsor ContactInformation
Name:	Michael Rabin, MD, CEO
Address:	Transdermal Cap, Inc.938 Chestnut RunGates Mills, OH 44040440-241-1846860-201-1846F
Name of Devices
Trade Names	LaserCap300, LaserCap224, LaserCap120,LaserCap80
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 (K160285, K143199)	Capillus, LLC
Capillus 202 (K160285, K153618)
Capillus 82 (K160285, K151516)
Reference Devices
Lasercomb82 (K142573)	Lexington International
Lasercomb41 (K142573)

Intended Use / Indications for Use

LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males with androgenetic alopecia who have Hamilton-Norwood classifications Ila-Vand for both genders, Fitzpatrick Classification of Skin Phototypes I to IV.

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Technological Characteristics

Performance Data

Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criteria were met by the device. The LaserCap300, LaserCap224, LaserCap120, and LaserCap80 conform to the standard IEC-60825-2007-03. This IEC standard is a recognized and accepted standard by the FDA. The guidance document for this accepted standard is found in the Federal register, July 26, 2001 (volume 66, Number 144). This report validates the LaserCap300, LaserCap224, LaserCap120, and LaserCap80 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliwatts maximum. With regard to all LaserCap models and predicate devices, there are no reported adverse events for this technology.

Non-clinical Testing

The LaserCap family of devices were tested for standards conformance with IEC 60825-1, IEC 60601-1-11, IEC 60601- 1-2, and IEC 62133. The materials used in LaserCap construction that come in contact with the skin are the same biocompatible materials as the predicates.

Substantial Equivalence

The LaserCap family of devices referenced in this application are the same technology used by the other Low Level Laser Therapy (LLT) devices cleared under device code OAP. The LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are as safe and effective as the predicate devices. The sponsor is certain that the difference in number of diodes is of no consequence and does not affect safety or efficacy as there are a wide range of number of diodes in the predicate devices listed and in other LLLT devices cleared under device code OAP. 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.

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	LaserCap Devices	Predicates
Device Trade Name	LaserCap300, LaserCap224, LaserCap120, LaserCap80 *	Capillus272, Capillus202, Capillus82 (K160285)
Device Type	LLLT	LLLT
Prescription	Yes	yes
Intended Use	Androgenetic Alopecia	Androgenetic Alopecia
Design	Helmet/Cap	Helmet/Cap
Laser Diode Power	<5mW	<5mW
Laser Diode Class	3R	3R
Wavelength	650nm	650nm
User Gender	Women; Men pending clearance	Women and Men
Passive Hands-free use	Yes	yes
Number of diodes	80, 120, 224, 300	82, 202, 272
Classification	OAP	OAP
Common Usage Name	Lamp, Non-heating	Lamp, Non-heating
Fitzpatrick Skin Phototypes	I-IV	I-IV
Ludwig-Savin Scale (women)	I-II	I-II
Norwood-Hamilton (men)	Ila-V (pending clearance)	lia-V
Treatment Frequency	17 weeks, every other day (indefinite)	17 weeks, every other day (indefinite)

LaserCap224 and LaserCap80 are legally marketed devices under the names LCPRO with 224 laser diodes and LCELITE with 80 laser diodes, respectively; K150613. Names changed in this submission for naming consistency with the proposed expanded family of LaserCap devices.

Based on technology, therapy outcome, similar design, wavelength choice, and treatment session time (all substantially equivalent), the expansion of the use for males from one device to

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its equivalent is reasonable and consistent with the known uses attributed to LLLT devices in general, and over a wide range in number of laser diodes, between devices. The predicate Capillus family of devices has been cleared for use in both men and women and there have been no reported safety issues with any LLLT device to date, with many indicated for use in both men and women. It is therefore established that there is no difference between the devices, the regimens, or the technology; and the number of diodes does not adversely affect the safety of the devices. Thus, the sponsor maintains that the indications for use for the submitted LaserCap devices should apply as stated: The LaserCap224, LaserCap224, LaserCap120, and LaserCap80 are indicated to promote hair growth in males with androgenic alopecia who have Norwood Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV. For these reasons, the LaserCap300, LaserCap224, LaserCap120, and LaserCap80 satisfy the FDA's substantial equivalence 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 androgenetic alopecia in both genders and that the red light lasers in class 3R, used in the LaserCap 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.

In summary, the LaserCap family of legally marketed devices and proposed new devices are essentially identical to the Capillus family of legally marketed devices, except for some small variations in number of laser diodes in the devices. And varying the number of laser diodes in these devices should not change safety or efficacy of these devices, as evidenced by predicate devices Capillus82 and Capillus202 which were new devices cleared by Special 510 (k) K151516 and K153618, respectively, using a 272 diode laser cap device as the predicate, and by reference devices Hairmax Lasercomb41 and Lasercomb82 for use in men and women (K142573) which were cleared using a 9 laser diode lasercomb as the predicate device.

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.