(90 days)
No
The summary describes a laser-based device for hair growth and explicitly states that no clinical performance data was produced because the device is identical to the predicate devices, with the only difference being the change from Rx to OTC. There is no mention of AI, ML, image processing, or any data sets typically associated with AI/ML development or validation.
Yes
The device is intended to promote hair growth in individuals with Androgenetic Alopecia, which addresses a medical condition.
No
The device is intended for promoting hair growth by using diode lasers. It does not perform any diagnostic functions like analyzing patient data, imaging, or making medical assessments. Its purpose is therapeutic.
No
The device description explicitly states it contains diode lasers configured within an outer cap helmet and protective inner liner, powered by a lithium-ion battery pack with an embedded controller chip. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a laser cap used to promote hair growth by applying light to the upper 1/3 of the head. This is a direct treatment applied to the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory results.
Therefore, the LaserCap Family of Lasers is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-IV.
Product codes
OAP
Device Description
The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. 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 LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical, as they are identical to the predicates and one and the same. The only difference between the Laser Models and the proposed device is the designation of Over-the-Counter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates, the LaserCap Family of Lasers, Models 300, 224, 120 and 80. The proposed devices and predicate devices are IDENTICAL and the same devices offered for sale with the only difference is Rx to OTC. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K193667, K181878, K180885, K173678
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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March 29, 2021
Transdermal Cap, Inc. % Raymond Blanche Consultant NST Consultants, Inc. 5 Cold Hill Road South Mendham, New Jersey 07945
Re: K203826
Trade/Device Name: LaserCap Family of Lasers 300, 224, 120 & 80 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 9, 2020 Received: December 29, 2020
Dear Raymond 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. 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.
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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) 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.
Purva Pandya 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
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Indications for Use
510(k) Number (if known) K203826
Device Name
LaserCap Family of Lasers, Models 300, 224, 120 and 80
Indications for Use (Describe)
Promoting hair growth in females with Androgenetic Alopecia who have Ludwig -Savin Classifications of I-II and males who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes of I-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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510(k) Summary
Revised March 24, 2021
K203826
Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consultants, Inc. |
| 5 Cold Hill Road South | |
| Unit 12 | |
| Mendham, NJ 07945 | |
| Telephone: | (973) 531-6226 |
| Facsimile: | (973) 539-7445 |
Name of Device and Name/Address of Sponsor
| Trade Name: | Lasercap Family of Lasers, Models 300, 224, 120 and 80 |
|---|---|
| Sponsor Contact | Laser Cap Company |
| Information: | Michael Rabin, MD. CEO |
| 26 Alpha Park | |
| Highland Heights, OH 44143 | |
| Telephone: 855-424-7774 | |
| 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 |
|---|---|
| LaserCap Family of Laser Models 300, 224, 120 and 80 | |
| (K150613) and (K161875) as Prescription Devices | Transdermal Cap, Inc. |
Reference Devices:
The following listed devices have been 510(k) Cleared as OTC Use.
Shapiro MD (K193667)
Cosmo Far East Technology Limited
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Kiierr Family of Lasers 272 and 148 (K181878) Hairmax Laser (K180885) Diode Laser (K173678).
Cosmo Far East Technology Limited Cosmo Far East Technology Limited Cosmo Far East Technology Limited
Date Prepared: March 12, 2021
Intended Use / Indications for Use
The LaserCap Family of Lasers, models 300, 224, 120 and 80 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II, and males who have Norwood-Hamilton Classifications of IIa – V and for both, Fitzpatrick Skin Phototypes I to IV.
Technological Characteristics
The LaserCap Family of Lasers, models 300, 224, 120 and 80 contains the listed number of diode lasers configured within an outer cap helmet and protective inner liner. 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 LaserCap models are powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical, as they are identical to the predicates and one and the same. The only difference between the Laser Models and the proposed device is the designation of Over-the-Counter.
Performance Data:
No clinical performance data was produced for this submission because the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 are the same device as the Predicates, the LaserCap Family of Lasers, Models 300, 224, 120 and 80. The proposed devices and predicate devices are IDENTICAL and the same devices offered for sale with the only difference is Rx to OTC. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime. LaserCap Family of Lasers, models, 300, 224, 120 and 80 has chosen to use a similar User Manual as the manufacturer of the 4 Reference Devices. Only the logo and color graphics have been altered to avoid unauthorized use, as well as any copyrighted language. A page-by-page analysis supports this use.
Substantial Equivalence
Both the LaserCap Family of Lasers, models 300, 224, 120 and 80 and the predicates use red light diode lasers, classified as class IIIa/3R laser systems by 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. The sponsor stipulates that there is no difference in the physical appearance or in the method of delivering the radiant energy of the two systems and therefore, there are no variations in the therapeutic value or safety profile.
For these reasons, the LaserCap Family of Lasers, Models, 300, 224, 120 and 80 Proposed Devices with an Intended use of OTC and the Predicates with an Intended Use of Rx, overwhelmingly satisfies the FDA's substantial equivalence with respect to intended use, technological and design characteristics.
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Treatment Protocol
The LaserCap Family of Lasers models 300, 224, 120 and 80 and the identified predicates, possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks.
The following Comparison Chart in support of substantial equivalence is provided: Predicates Devices (K150613),(K161875)
| Specification Category | LaserCap Family of Lasers
(K203826) | LaserCap Family of Lasers (K150613),(K161875)
Models 300, 224, 120 and 80 |
|------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| | Proposed Device for OTC Use | Predicate with Rx Indication for Use |
| LLLT Device Type | Laser Diode | Laser Diode |
| Use Application | OTC | Rx |
| Intended Use Androgenetic Alopecia | Androgenetic Alopecia | Androgenetic Alopecia |
| Contain Laser Diodes-Class 3R | 300, 224, 120, 80, 5 milliwatts each. | 300, 224, 120, 80, 5 milliwatts each. |
| Physical Design of Device | Helmet | Helmet |
| Wavelength | 650+/-5 NMS. | 650+/-5 NMS. |
| Marketing Clearance | For females and males, OTC | For females and males Rx |
| Use Type | Passive Use-Hands Free | Passive Use-Hands Free |
| Classification Code | OAP | OAP |
| Classification Name | Infrared Lamp | Infrared Lamp |
| Common Usage Name | Lamp, Non-Heating | Lamp, Non-Heating |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery |
| Skin Phototypes | I- IV | I- IV |
| Hair Loss Classification | Hamilton-Norwood IIa-V for males
Ludwig-Savin I - II for females | Hamilton-Norwood IIa-V for males
Ludwig-Savin I – II Hair for females |
| Treatment Regime | 16 weeks, for 30-minute treatment times
three times a week, on alternate days. | 16 weeks, for 30-minute treatment times
three times a week, on alternate days. |
| Device Class | II | II |
The data presented in the Comparison Chart, demonstrates that the LaserCap Family of Lasers, models 300, 224, 120 and 80 are identical and equivalent, to the predicates, the same devices Cleared with an Rx Intended Use. Based on this comparison and determination, the sponsor requests the FDA to clear the device via the 510(k) notice.
Over - The - Counter Testing Program
No OTC testing was performed for this submission because the User Manual and packaging contents for the predicates and reference devices, are substantially equivalent to the Reference Devices. While some of the language contained in the User Manuals of the Reference devices may differ, these differences do not alter the Self Selection, Hazards and Precautions, or Usability criteria. The only major exception is color and logo of the subject device literature. The graphic changes do not alter the User Manual, the key variable in any OTC testing evaluation. The aesthetic appearance of the proposed devices devices and the
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reference devices all use the same exterior black shell and interior clear shells. The dimensions of the shells are also equivalent.
Electrical Safety and Electromagnetic Compatibility Testing Performance
The LaserCap Family of Lasers, Models 300, 224, 120 and 80 were evaluated for conformance to recognized international standards.
Biocompatibility, electrical safety and EMC testing is not needed in this submission because the subject device is identical to the predicate devices in these aspects.
Shelf Life
The Usable life expectancy for this device is 10,000 hours based on the specifications for the laser diode and 5 years for the overall usable life of the LaserCap Family of Lasers, Models 300, 224, 120 and 80.
Conclusion
Based on the technical comparisons between the LaserCap Family of Lasers, models 300, 224, 120 and 80, 510(k) Cleared for Rx Use (K150613), (K161875) are the same as the Proposed devices, only with a new Intended Use as OTC. It can be concluded that the proposed devices are substantially equivalent to the predicate devices in technical specifications. Since the proposed devices are currently being marketed with a prescription-use indication, therefore, with no modifications in manufacturing, the proposed devices and predicates do not raise any issues of safety or efficacy.
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the devices are as safe and as effective and perform as well as or better than the predicate devices.