(22 days)
Not Found
No
The device description and performance studies focus on laser technology and electrical safety, with no mention of AI or ML.
Yes
The device is intended to treat Androgenetic Alopecia and promote hair growth, which are therapeutic uses.
No
Explanation: The device is intended to treat Androgenetic Alopecia and promote hair growth, which is a therapeutic function, not a diagnostic one. It uses visible light lasers for treatment.
No
The device description explicitly states that the device consists of physical components including diode lasers, an outer helmet, inner liner, rechargeable battery, and adapter. It also mentions performance testing related to laser class and charger standards, indicating hardware components are central to the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat Androgenetic Alopecia and promote hair growth." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a laser-based system for applying light to the scalp. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
The device is clearly intended for direct treatment of a condition on the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Capillus302, Capillus312, and Capillus352 consist of 302, 312, or 352 (respectively) 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. These models are exactly the same as the (predicate) Capillus family of devices (Capillus272, Capillus202, Capillus82) with the exception of the number of diodes. 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 (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Capillus302, Capillus352 conform to the standard IEC-602825-2007-03. This IEC standard is a recognized and accepted standard by the FDA. This report validates for the Capillus312, and Capillus352 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 61959.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2016
Capillus, LLC Ms. Patricia Schnoor Director, Quality, Safety, and Compliance 1715 NW 82nd Avenue Miami, Florida 33126
Re: K162994
Trade/Device Name: Capillus302. Capillus312. Capillus352 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: October 24, 2016 Received: October 27, 2016
Dear Ms. Schnoor:
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.
1
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,
Jennifer R. Stevenson -A
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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Indications for Use
510(k) Number (if known)
Device Name Capillus302, Capillus312, Capillus352
Indications for Use (Describe)
The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of Ila to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-2, or frontal; both with 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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510(k) Summary
Capillus, LLC
| Date Prepared: | October 24, 2016 |
|---|---|
| Submitter's Contact Information: | |
| Name: | Patricia Schnoor |
| Address: | Capillus LLC |
| 1715 NW 202nd Avenue | |
| Miami, FL 33126 | |
| Establishment | |
| Registration#: | 3010123655 |
| Telephone: | (786) 888-1874 |
| Facsimile: | (305) 418-7581 |
| Name of Device and Name / Address of Sponsor: | |
| Trade Name: | Capillus302, Capillus312, Capillus352 |
| 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) |
| Sponsor Contact Information: | Patricia Schnoor |
| Capillus LLC | |
| 1715 NW 82nd Avenue | |
| Miami, FL 33126 | |
| Telephone: | (786) 888-1874 |
Predicate Devices:
| Device Trade Name | Manufacturer | 510(k) |
|---|---|---|
| Capillus family of devices | Capillus LLC | 160285 |
| LaserCap | Transdermal Cap | 161875 |
Intended Use / Indications for Use:
The Capillus302, Capillus312, and Capillus352, are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-1 to I-4, II-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
4
Technological Characteristics
The Capillus302, Capillus312, and Capillus352 consist of 302, 312, or 352 (respectively) 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. These models are exactly the same as the (predicate) Capillus family of devices (Capillus272, Capillus202, Capillus82) with the exception of the number of diodes.
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 (2 short beeps) or ended (one long beep). The portable systems are powered by rechargeable Li-Ion battery cells assembled into a proprietary battery pack. Both the battery 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 Capillus302, Capillus352 conform to the standard IEC-602825-2007-03. 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) [page 39049 39050]. This report validates for the Capillus312, and Capillus352 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 61959.
Just as for Capillus family of devices (K160285), there are no reported adverse events for this technology.
Substantial Equivalence
The Capillus family of devices referenced in this application are the same technology used by the LLLT devices cleared under device code OAP. The Capillus302, Capillus312, and Capillus352 are as safe and effective as the predicate devices, as well as other reference devices in its class.
The sponsor believes that the difference in the physical appearance, number of diodes, or in the method of delivering the radiant energy of the systems is of no consequence and does not affect the therapeutic value or the safety profile. All compliant LLLT systems which use red light diode lasers are 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.
5
| Capillus Devices | LaserCap | Capillus 302, 312, 352 |
|---|---|---|
| K160285 | K161875 | Candidate |
| LLLT Device Type | LLLT Device Type | LLLT Device Type |
| Prescription Use | Prescription Use | Prescription Use |
| Intended Use - Androgenic Alopecia | Intended Use - Androgenic Alopecia | Intended Use - Androgenic Alopecia |
| Contain Laser Diodes- Class 3R | Contain Laser Diodes- Class 3R | Contain Laser Diodes- Class 3R |
| Helmet/Cap Design | Helmet/Cap Design | Helmet/Cap Design |
| 5mW max | 5mW max | 5mW max |
| 650nm | 650nm | 650nm |
| Marketing clearance for Males and Females | Marketing clearance for Males and Females | Marketing clearance for Males and Females |
| Passive Use-Hands Free | Passive Use-Hands Free | Passive Use-Hands Free |
| 82, 202, 272 Laser Diodes | 80, 120, 224, 300 Laser Diodes | 302, 312, 352 Laser Diodes |
| OAP Classification | OAP Classification | OAP Classification |
| Classification Name -Infrared Lamp | Classification Name -Infrared Lamp | Classification Name -Infrared Lamp |
| Common Usage Name - Lamp, Non-Heating | Common Usage Name - Lamp, Non-Heating | Common Usage Name - Lamp, Non-Heating |
| General & Plastic Surgery Committee | General & Plastic Surgery Committee | General & Plastic Surgery Committee |
| Fitzpatrick Skin Phototypes - I- IV | Fitzpatrick Skin Phototypes - I- IV | Fitzpatrick Skin Phototypes - I- IV |
| Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) |
| Norwood Hamilton IIA-V (males) | Norwood Hamilton IIA-V (males) | Norwood Hamilton IIA-V (males) |
| Efficacy Rates - High Compared to Placebo | UNK | Efficacy Rates – 51% (calculated) |
| Treatment- 17 weeks, every other day | Treatment- 17 weeks, every other day | Treatment- 17 weeks, every other day |
| (indefinite) | (indefinite) | (indefinite) |
| Device Class II | Device Class II | Device Class II |
For these reasons, the Capillus312, and Capillus352 satisfy the FDA's substantial equivalence requirements 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 androgenic alopecia in both genders and that the red light lasers in class 3R, used in the Capillus 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.
Signed:
Pat Ansel
Patricia Schnoor Director, QA/RA