(45 days)
Not Found
No
The device description focuses on the hardware components (lasers, battery, helmet) and basic functionality (audible tones). There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on compliance with laser safety standards, not algorithmic performance.
Yes.
The device is intended to treat Androgenetic Alopecia and promote hair growth, which are therapeutic claims.
No
The device is intended to treat Androgenetic Alopecia and promote hair growth, which are therapeutic functions, not diagnostic ones. It does not mention any capabilities for detecting, analyzing, or diagnosing medical conditions.
No
The device description explicitly details hardware components including laser diodes, a helmet, a rechargeable battery, and an adapter.
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 examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Capillus X and Capillus X+ are laser domes that apply light therapy directly to the scalp. They do not analyze any biological samples taken from the body.
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth by applying light to the scalp. This is a therapeutic application, not a diagnostic one based on analyzing samples.
The device description and intended use clearly indicate that this is a therapeutic device that interacts with the body externally, not an IVD that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The Capillus X and Capillus X+ laser domes are intended to treat Androgenetic Alopecia and promotion of hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treating Androgenetic Alopecia and promotion of hair growth in females who have Ludwig (Savin) Scale 1-4, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
The CapillusX and CapillusX+ 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
OAP
Device Description
The CapillusX and CapillusX+ consist of 112 and 244 (respectively) 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. These models are exactly the same as the (predicate) Capillus family of devices (CapillusPro, 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 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
Over-The-Counter 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
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 CapillusX+ 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 CapillusX and CapillusX+ the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "U.S. FOOD & DRUG" is on the top line, and "ADMINISTRATION" is on the bottom line.
Capillus Patricia Schnoor Director, QA/RA 1715 NW 82nd Ave. Doral, Florida 33126
September 12, 2019
Re: K192012
Trade/Device Name: Capillus 112, Capillus 244 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: July 26, 2019 Received: July 29, 2019
Dear 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. 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.
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
1
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,
Neil R.P. Ogden, Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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)
Device Name CapillusX, CapillusX+
Indications for Use (Describe)
The Capillus X and Capillus X+ laser domes are intended to treat Androgenetic Alopecia and promotion of hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and treating Androgenetic Alopecia and promotion of hair growth in females who have Ludwig (Savin) Scale 1-4, 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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K192012
510(k) Summary
Capillus, LLC
| Date Prepared: | September10, 2019 |
|---|---|
| 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: | CapillusX, CapillusX+ |
| 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) |
|---|---|---|
| CapillusPro | Capillus LLC | 163170 |
| Capillus82 | Capillus LLC | 163170 |
Intended Use / Indications for Use:
The CapillusX and CapillusX+ 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.
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Technological Characteristics
The CapillusX and CapillusX+ consist of 112 and 244 (respectively) 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. These models are exactly the same as the (predicate) Capillus family of devices (CapillusPro, 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 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 CapillusX+ 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 CapillusX and CapillusX+ the laser class of 3R which establishes the AEL (accessible emission limits) as 5 milliWatts maximum. The charger conforms to IEC 60601-1.
Just as for the currently cleared Capillus family of devices, there are no reported adverse events for this technology.
Substantial Equivalence
The Capillus devices referenced in this application are the same technology used by the LLLT devices cleared under device code OAP. The CapillusX and CapillusX+ 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 LLT 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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| CapillusPro | Capillus82 | CapillusX / CapillusX+ |
|---|---|---|
| K162994 | K162994 | Candidate |
| LLLT Device Type | LLLT Device Type | LLLT Device Type |
| Over the Counter Use | Over the Counter Use | Over the Counter 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 |
| 1360mW max energy | 410mW max energy | 560mW / 1220mW max energy |
| 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 |
| 272 Laser Diodes | 82 Laser Diodes | 112 / 244 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 | Same as for MEP-90 (predicate) | Efficacy Rates -35-48% (calculated) |
| Treatment- 17weeks, 6 min daily (indefinite) | Treatment- 6 min daily (indefinite) | Treatment- 6 min daily (indefinite) |
| Device Class II | Device Class II | Device Class II |
For these reasons, the CapillusX and CapillusX+ satisfy the FDA's substantial equivalence requirements with respect to intended use, and 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