(84 days)
No
The device description focuses on the physical components and laser technology, with no mention of AI or ML. The performance studies also do not indicate the use of such technologies.
Yes
The device is intended for the "promotion of hair growth in females with androgenetic alopecia" and "males with androgenetic alopecia," indicating a therapeutic purpose of treating a medical condition (androgenetic alopecia) by promoting hair growth.
No
The device is intended for the promotion of hair growth, not for diagnosing a medical condition.
No
The device description explicitly states it consists of physical components like diode lasers, an outer helmet, inner liner, rechargeable battery, and adapter, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "promotion of hair growth" in individuals with androgenetic alopecia. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device uses visible light lasers to stimulate hair growth. It does not involve analyzing biological samples (like blood, urine, or tissue) to diagnose a condition or monitor a patient's health status.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
LaserCap300, LaserCap224, LaserCap120, and LaserCap80 are intended for the promotion of hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of 1 - 11 and males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and for both, Fitzpatrick Skin Phototypes I to IV.
Product codes
OAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hair-bearing areas of the scalp
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160285, K143199, K153618, K151516
Reference Device(s)
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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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
1
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)
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.
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 Contact
| Information | |
|---|---|
| Name: | Michael Rabin, MD, CEO |
| Address: | Transdermal Cap, Inc. |
| 938 Chestnut Run | |
| Gates Mills, OH 44040 | |
| 440-241-1846 | |
| 860-201-1846F | |
| 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
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.
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 |