(92 days)
No
The summary describes a low-level laser device for hair growth and does not mention any AI or ML components or functionalities.
Yes.
The device is indicated to treat Androgenetic Alopecia and promote hair growth. The mention of "treat" and "promote hair growth" signifies a therapeutic intent, which directly relates to the medical treatment of a condition rather than merely diagnostic or preventative purposes.
No
The device is indicated to treat hair loss and promote hair growth, which are therapeutic functions. It does not mention diagnosing any conditions.
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:
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a low-level laser device that delivers light to the scalp. This is a physical intervention, not a test performed on biological samples outside the body.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (like blood, urine, tissue, etc.) which is a key characteristic of IVDs.
- Anatomical Site: The device is applied to the scalp, which is a direct application to the body, not an in vitro test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia 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-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 family of DermaScalp 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 Males and 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, 18)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
User comprehension of user instructions, warnings, and precautions was determined through a self-selection and usability study administered by a third-party group.
Sample Size: 116 adult subjects of any age (>18) of diverse race, age, and educational background.
Key Results: The DermaScalp usability test demonstrated a pass rate of 93% (self-selection) and 99.4% pass rate for the user instruction questionnaire, satisfying the FDA's requirements for clearance (sale) as Over-the-Counter Intended Use. Performance testing was conducted to confirm compliance to design specifications, and all functions were verified to operate as designed. The DermaScalp devices met all acceptance criteria in the performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pass rate in self-selection: 93%
Pass rate for user instruction questionnaire: 99.4%
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.
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/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue to the right of the square.
March 21, 2018
DermaScalp LLC John Carullo Managing Member 190 E. Stacy Rd Suite 306-291 Allen, Texas 75002
Re: K173846
Trade/Device Name: D DermaScalp Laser Cap Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: December 14, 2017 Received: December 19, 2017
Dear John 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -S3
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
2
Indications for Use
510(k) Number (if known) K173846
Device Name DermaScalp Laser Cap
Indications for Use (Describe)
The family of DermaScalp Laser Cap devices are indicated to treat Androgenetic Alpopecia 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-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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ATTACHMENT 2
510(k) SUMMARY
| 510(k) Owner: | DermaScalp LLC
190 E. Stacy Rd.
Suite 306-291
Allen, TX 75002
Contact: John Carullo
Phone: 214-683-0724 | | | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------|-----------------------------|---------------------------------------------------------------------------------------|-----------------|----------|
| Date Summary Prepared: | December 14, 2017 | | | | | | |
| Device: | Trade Name:DermaScalp Laser CapsCommon/Classification Name:Light Therapy Hair System
Product Code OAP
21 C.F.R. § 890.5500 (Infrared lamp)Classification:Class II | Trade Name: | DermaScalp Laser Caps | Common/Classification Name: | Light Therapy Hair System
Product Code OAP
21 C.F.R. § 890.5500 (Infrared lamp) | Classification: | Class II |
| Trade Name: | DermaScalp Laser Caps | | | | | | |
| Common/Classification Name: | Light Therapy Hair System
Product Code OAP
21 C.F.R. § 890.5500 (Infrared lamp) | | | | | | |
| Classification: | Class II | | | | | | |
| Predicate Devices: | iGrow II Hair Growth System - Apira Science Inc - K152019
Capillus82, Capillus202, Capillus272 Pro, 272 OfficePro, Capillus302, Capillus312, and Capillus352 – Capillus LLC – K163170
Transdermal LaserCap80, LaserCap120, LaserCap224, LaserCap300 – K161875 | | | | | | |
| Reference Device: | DermaScalp Laser Cap - DermaScalp LLC - K152587 (Previously FDA cleared) | | | | | | |
4
| Device
Description: | The family of DermaScalp 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 Males and 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,
18) of diverse race, age, and educational background. The DermaScalp usibility test demonstrated a pass rate of 93% (self-selection) and 99.4% pass rate for the user instruction questionnaire, satisfying the FDA's requirements for clearance (sale) as Over-the-Counter Intended Use.
Performance Testing is conducted to confirm compliance to design specifications; all functions were verified to operate as designed. The DermaScalp devices met all acceptance criteria in the performance testing.
Substantial The family of DermaScalp Laser Cap devices referenced in this application are Equivalance: the same technology used by the LLLT devices cleared under device code OAP. The DermaScalp Laser Caps 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 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.
| DermaScalp Devices | Capillus Devices | Transdermal Devices | iGrow | OAP Devices (General) |
|---|---|---|---|---|
| To Be Determined | K163170 | K161875 | K152019 | N/A |
| LLLT Device | LLLT Device | LLLT Device | LLLT Device | LLLT Device |
| OTC | OTC | Prescription | OTC | Prescription and OTC |
| Intended Use- | ||||
| Androgenetic Alopecia | Intended Use- | |||
| Androgenetic Alopecia | Intended Use- | |||
| Androgenetic Alopecia | Intended Use- | |||
| Androgenetic Alopecia | Intended Use- | |||
| Androgenetic Alopecia | ||||
| Cap Design | Cap Design | Cap Design | Helmet Design | Helmet/Cap, Comb, Brush or Panel Design |
| 650nm | 650nm | 650nm | 655nm | 635-678nm |
| Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females | Marketing Clearance for Males & Females |
| Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free) | Passive Use (hands free or comb) |
6
| Diode Count- 50, 80,
120, 148, 180, 202,
224, 272 | Diode Count- 82,
202, 272, 302, 312,
352 | Diode Count- 80,
120, 224, 300 | Diode Count- 51 | Diode Count- Ranges
from
1 to 352 |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------------------------------|
| Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP | Classification: OAP |
| Fitzpatrick Skin
Phototypes - I-IV | 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) | Ludwig-Savin I-II
(females);
Norwood Hamilton
IIA-V (males);
or both genders |
| Norwood Hamilton IIA-
V (males) | Norwood Hamilton
IIA-V (males) | Norwood Hamilton
IIA-V (males) | Norwood Hamilton
IIA-V (males) | |
| Treatment- 17weeks,
every other day
(indefinite) | Treatment- 17weeks,
every other day
(indefinite) | Treatment-
17weeks, every
other day (indefinite) | Treatment-
17weeks, every
other day
(indefinite) | Treatment-
approximately
17weeks, every
other day (indefinite) |
| Total Laser Energy
Output: