(147 days)
Not Found
No
The description focuses on the physical characteristics and laser technology of the device, with no mention of AI or ML. The performance studies also focus on laser parameters and electrical/EMC safety, not algorithmic performance.
Yes
The device is indicated to "promote hair growth in females with Androgenetic Alopecia," which is an indication for treating a medical condition.
No
The device is intended to promote hair growth and treat hair loss, which are therapeutic actions, not diagnostic ones. It does not identify or characterize a disease.
No
The device description explicitly states it is a "low-level laser device" and describes physical components like a "Concave' scalp covering utilizing laser modules". This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The DermaScalp Laser Cap is a device that applies low-level laser light directly to the scalp. It is a physical device used externally on the body.
- Intended Use: The intended use is to promote hair growth in females with Androgenetic Alopecia. This is a therapeutic or cosmetic application, not a diagnostic test performed on a sample.
The device's function and intended use clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have Fitzpatrick Skin Types I to IV.
Product codes
OAP
Device Description
The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices are a hands-free, portable, non-invasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Females. The DermaScalp Laser Cap devices provide distributed red laser light dispersing from a "Concave" scalp covering utilizing laser modules with a 650 nm wavelength,
§ 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 shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2016
Dermascalp LLC Mr. John Carullo Managing Member 1700 Alma Drive Suite 400 Plano, Texas 75075
Re: K152587
Trade/Device Name: DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: November 20, 2015 Received: January 4, 2016
Dear Mr. Carullo:
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.
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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 yours,
Jennifer R. Stevenson -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) K152587
Device Name
DermaScalp Laser Cap Models: DermaScalp MD Laser Cap & DermaScalp MDX Laser Cap
Indications for Use (Describe)
The DermaScalp Laser Cap is indicated to promote hair growth in females with Androgenetic Alpopecia who have Ludwig-Savin Classifications I-II and who have 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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ATTACHMENT 2
510(k) SUMMARY
| 510(k) Owner: | DermaScalp LLC
1700 Alma Dr. Suite 400
Plano, TX 75075
Contact: John Carullo
Phone: 214-683-0724 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Summary Prepared: | Sebtember 04, 2015 |
| Device: | |
| | Trade Name: DermaScalp Laser Cap |
| | Common/Classification Name: Light Therapy Hair System
Product Code OAP |
| | 21 C.F.R. § 890.5500 (Infrared lamp) |
| | Classification: Class II |
| Predicate Devices: | LaserCap Elite - Transdermal Cap Inc - K150613
LaserCap PRO - Transdermal Cap Inc - K150613 |
| Device Description: | The DermaScalp MD Laser Cap and the DermaScalp MDX Laser Cap devices
are a hands-free, portable, non-invasive, low-level laser device intended to
treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in
Females. The DermaScalp Laser Cap devices provide distributed red laser
light dispersing from a "Concave" scalp covering utilizing laser modules with
a 650 nm wavelength,