(77 days)
No
The device description and performance studies focus on laser technology and compliance with laser safety standards, with no mention of AI or ML.
Yes
The device is indicated to "promote hair growth" for androgenic alopecia, which is a medical condition, making it a therapeutic device.
No
The "Intended Use / Indications for Use" section states that the device is "indicated to promote hair growth," which is a treatment, not a diagnosis. There is no mention of it analyzing, detecting, or identifying any medical condition.
No
The device description explicitly states it consists of hardware components: 82 red diode lasers, an outer helmet, inner liner, rechargeable battery, and adapter.
Based on the provided information, the Capillus82 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Capillus82 Function: The Capillus82 is a device that uses laser light applied externally to the scalp to promote hair growth. It does not involve testing samples taken from the body.
- Intended Use: The intended use clearly states it's for promoting hair growth in individuals with androgenic alopecia, which is an external application of energy.
Therefore, the Capillus82 falls under the category of a therapeutic or physical medicine device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Capillus82 consists of 82 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. Just as for the previous version, 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 re-established. 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 Nickel Metal Hydride 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
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 criterion were met by the device. The Capillus82 conforms to the standard IEC-60825-2007-03. This report validates for the Capillus82 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 61959. The performance data available for review demonstrates that the Capillus82 has exactly the same laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area as the original Capillus272 Pro cleared under K143199. Total “dose” - delivered energy over time - (J/cm') is logically reduced. Just as for Capillus272 Pro (K143199) and reference devices, there are no reported adverse events for this technology.
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.
K143199, K113097, K122950, K091496
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.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three intertwined strands and three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2015
Capillus LLC Ms. Patricia Schnoor Quality, Safety and Compliance Manager 1715 North West 82nd Avenue Miami, Florida 33126
Re: K151516
Trade/Device Name: Capillus 82 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: July 20, 2015 Received: July 23, 2015
Dear Ms. Patricia 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 (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.
Sincerely yours.
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
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Indications for Use
510(k) Number (if known) K151516
Device Name Capillus 82
Indications for Use (Describe)
The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of 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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Special 510(k) Summary K151516
Capillus, LLC
Date Prepared:
June 22, 2015
Submitter's Contact Information:
| Name: | Patricia Schnoor |
|---|---|
| Address: | Capillus LLC |
| 1715 NW 82nd Avenue | |
| Miami, FL 33126 | |
| Estab't Reg#: | 3010123655 |
| Telephone: | |
| Facsimile: | (786) 888-1874 |
| (305) 418-7581 |
Name of Device and Name / Address of Sponsor:
| Trade Name: | Capillus82 |
|---|---|
| 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) |
|---|---|---|
| Capillus272 Pro | Capillus LLC | 143199 |
| Laser Helmet | Theradome | 113097 |
| 122950 | ||
| MEP-90 | Midwest RF LLC | 091496 |
Reference Devices:
| Device Trade Name | Manufacturer |
|---|---|
| Hairmax Lasercomb | Lexington International |
Intended Use / Indications for Use:
The Capillus82 is indicated to promote hair growth in females who have androgenic alopecia and Ludwig-Savin Classifications of I- II; and with Fitzpatrick Classification of Skin Phototypes I to IV.
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Technological Characteristics
The Capillus82 is exactly the same as the Capillus272 Pro in every way except the following:
1. The Capillus82 has fewer diodes – 82 compared to 272 for Capillus272 Pro
The Capillus272 Pro consists of 272 red, visible light, diode lasers operating at 650 nanometers, configured within an outer helmet and protective inner, and configured for portable use with rechargeable battery and adapter. The Capillus82 consists of 82 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.
Just as for the previous version, 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 re-established. 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 Nickel Metal Hydride battery cells assembled into a proprietary battery pack. Both the battery pack and charger are fully compliant to recognized, international standards.
Design Control Activities:
The Capillus design and development team followed ANSI/AAMI/ISO 14971:2007/(R)2010 Risk Management: Medical devices - Application of risk management to medical devices. Significant changes included assessing the effect a reduction of lasers would have on the end product, both for safety and for efficacy. All residual risks are found acceptable and the risk management file and summary are available for review. Based on the Capillus272 Pro, the verification and validation activities remain the same (e.g. output of each laser, operation of safety interface, and output of power pack), and were performed and assessed by designated personnel qualified to perform such activities. All methods, tests, and acceptance criteria are stipulated on the verification reports. All documents are available for review.
Safety ratings remained the same; there was no change to the individual lasers (≤ 5mW); however, the "dose" (total delivered energy/cm2) is reduced number of lasers. This may affect efficacy; this observation is made based on the performance of other devices similar to Capillus that are currently cleared under device code OAP and utilize much fewer than 272 lasers (The closest equivalent in light sources is Apira with a total of 78 lasers and LEDs - mixed).
Use instructions do not change. Indications for use and the dose schedule remain exactly the same as for Capillus272 Pro and as for other devices in the same category (product code OAP); which is for maximum 30 minutes, every other day.
The output of the laser diodes was verified to remain the same (each diode) as for the previous model. Design control activities were followed per 21 CFR 820.30:
5
- a) General: The Capillus LLC Quality Management System is compliant to the requirement of the quality system regulation and specifically to design controls as stipulated by 21 CFR 820.30.
- b) Design and development planning: During project planning activities, the risks were identified and assessed with respect to the proposed design change. The proposed design change was minimal and affected only the number of diodes in the PCB array. The power pack remains exactly the same. Review of the risk assessment from previous model revealed no significant changes or risks are identified for the new model Capillus82. Vigilance activities for the Capillus272 Pro indicated that there were no significant problems identified (no adverse events reported).
- c) Design input: Design requirements for the Capillus272 Pro are transferred to the Capillus82 and an input/output matrix completed as for the original project.
- d) Design output: Design requirements for the Capillus272 Pro are transferred to the Capillus82 and an input/output matrix completed as for the original project. Design outputs are verified per performance tests.
- e) Design review: Appropriate design reviews were conducted; in this case (due to minimal change), a technical evaluation, and a verification of inputs and outputs (physical values) were completed.
- f) Design verification: All verification activities to assess the impact of the change (reduction of number of laser diodes) were completed. Laser diode output remains the same, but dosage is reduced. Since the cap is intended to be used indefinitely (if treatment is stopped, results are lost see instructions for use), this will likely affect only the time required to witness the same result as achieved with the Capillus272 Pro. The Capillus82 is offered as a lower-cost alternative.
- g) Design validation: Feedback from hair restoration specialists and consumers indicate that a lower-cost alternative is desired. The slower efficacy is accepted, with the understanding that treatment is intended to be indefinite.
- h) Design transfer: The Capillus family of products are manufactured on-site in the factory in Miami. Design transfer was minimal; training to the new PCB was minimal, and all other components (including overall build) remained the same.
- Design changes: The design of all models follows our established design control, change control, i) document control procedures.
- Design history: The design history file for the Capillus82 is available for review. i)
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Performance Data:
All verification and validation activities were performed by designated individuals. The results (available for review) demonstrate that the predetermined acceptance criteria were met.
Performance testing was conducted to confirm compliance to design specifications; all functions have been verified to operate as designed. All acceptance criterion were met by the device.
The Capillus82 conforms 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) [page 39049 39050]. This report validates for the Capillus82 the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 61959.
The performance data available for review demonstrates that the Capillus82 has exactly the same laser wavelength, output power (per diode), output beam, energy type, laser field, and treatment area as the original Capillus272 Pro cleared under K143199. Total "dose" - delivered energy over time - (J/cm') is logically reduced. Just as for Capillus272 Pro (K143199) and reference devices, there are no reported adverse events for this technology.
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Substantial Equivalence
The Capillus82 is the same technology used by Capillus272 Pro (K143199) and other reference devices; specifically, Theradome Laser Helmet (K113097 & K122950). The Capillus82 is as safe and (commensurate to number of diodes) effective as the Capillus272 Pro, as well as other reference devices in its class, such as the Laser Helmet and Hairmax Lasercomb.
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| Capillus272 Pro | Capillus82 | Laser Helmet | MEP-90 |
|---|---|---|---|
| K143199 | Candidate | K113097, K122950 | K091496 |
| LLLT Device Type | LLLT Device Type | LLLT Device Type | LLLT Device Type |
| Prescription Use | Prescription Use | Prescription & OTC Application | Prescription Use |
| Intended Use - Androgenic Alopecia | Intended Use - Androgenic Alopecia | Intended Use -Androgenic Alopecia | Intended Use -Androgenic Alopecia |
| Contain Laser Diodes- Class 3R | Contain Laser Diodes- Class 3R | ContainLaserDiodes-Class3R | ContainLaserDiodes-Class3R |
| Helmet/Cap Design | Helmet/Cap Design | Helmet Design | Helmet Design |
| 650nm | 650nm | 678nm | 650nm |
| Marketing clearance for Females | Marketing clearance for Females | Marketing clearance for both genders | Marketing clearance for females |
| Passive Use-Hands Free | Passive Use-Hands Free | Passive Use-Hands-Free | Passive Use-Hands-Free |
| 272 Laser Diodes | 82 Laser Diodes | 80 Laser Diodes | 82 Laser Diodes |
| OAP Classification | OAP Classification | OAPClassification | OAPClassification |
| Classification Name -Infrared Lamp | 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 | Common Usage Name - Lamp, Non- Heating |
| General & Plastic Surgery Committee | 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 | Fitzpatrick Skin Phototypes - I -IV |
| Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) | Ludwig-Savin I-II (females) |
| Norwood-Hamilton Classification IIa-V (males) | |||
| Efficacy Rates - High Compared to Placebo | Efficacy Rates - High Compared to Placebo | Efficacy Rates - Increased Compared to | Efficacy Rates - Increased Compared to |
| Placebo | Placebo | ||
| Treatment- 17weeks, every otherday | Treatment- 17 weeks, every otherday | Treatment - 16 weeks, every otherday | Treatment - 20 weeks, every otherday |
| (indefinite) | (indefinite) | (indefinite) | (indefinite) |
| Device Class II | Device Class II | Device Class II | Device Class II |
9
Capillus LLC believes that with the exception of the ontiguration of the optical elements, the Capillus82 is the same device in form, function, safety, and efficacy as the previous version and the predicate device, Laser Helmet. The Laser Helmet, with 80 laser diodes, is proof of the functionality and acceptability of devices with fewer laser diodes cleared by the FDA in the category of OAP, both technically. Capillus LLC 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 classified as class 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.
For these reasons, the Capillus82 satisfies the FDA's requirements (for device modification) with respect to intended use, and technological and design characteristics. Additionally, no new safety or efficacy concerns are raised due to the minor difference present between devices.
Signed:
Patricia Schnoor Quality, Safety & Compliance Manager K151516 Page 7 of 7