(134 days)
No
The device description focuses on laser technology and a safety interlock mechanism, with no mention of AI or ML capabilities.
Yes.
The device is indicated to "promote hair growth in females with androgenetic alopecia," which describes a medical condition and a therapeutic effect.
No
Explanation: The device is described as promoting hair growth using lasers and does not mention any function for diagnosis or detection of a disease state. Its purpose is therapeutic, not diagnostic.
No
The device description clearly details hardware components, specifically diode lasers, a helmet, a safety interlock, and a battery system. It is not solely software.
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 LC PRO and LC ELITE are described as devices that use laser light applied externally to the head to promote hair growth. They do not involve the analysis of any biological specimens.
- Intended Use: The intended use is to promote hair growth, not to diagnose, monitor, or screen for a disease or condition through the analysis of in vitro samples.
- Device Description: The description focuses on the physical components of the helmet and the laser technology, not on any components related to handling or analyzing biological samples.
Therefore, the LC PRO and LC ELITE fall under the category of therapeutic devices that apply energy externally to the body, rather than IVDs.
N/A
Intended Use / Indications for Use
The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. 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 reestablished. 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 Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells 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
upper 1/3 of the head
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)
No Clinical trial data for LCPro and LCElite were submitted for this 510(k). The LCPro and LCElite were tested for standards conformance with IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133.
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.
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Transdermal Cap Incorporated % Mr. Raymond R. Blanche NST Consulting, LLC 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
July 22, 2015
Re: K150613
Trade/Device Name: LaserCap LCPro and LCElite Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Class II Product Code: OAP Dated: June 17, 2015 Received: June 19, 2015
Dear Mr. Blanche:
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.
Sincerelv vours.
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) K150613
Device Name LaserCap LCPro and LCElite
Indications for Use (Describe)
The LC PRO and LC ELITE are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I-II and Fitzpatrick Classification of skin phototypes of I-IV.
Type of Use (Select one or both, as applicable)
| ☑ Export under an IDP with a DE1191 Statement. Please see instructions. | ☐ This is a one-time-only Export. |
|---|---|
| ------------------------------------------------------------------------- | ----------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
Transdermal Cap, Inc.
Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consulting, LLC |
| 641 Shunpike Road, Suite 311 | |
| Chatham, NJ 07928 | |
| Telephone: | |
| Facsimile: | (973) 539-7444 |
| (973) 539-7445 |
Name of Device and Name/Address of Sponsor
| Trade Name: | Lasercap, LCPro and LCElite |
|---|---|
| Sponsor Contact | |
| Information: | Michael Rabin, MD |
| Transdermal Cap, Inc. | |
| 3615 Superior Avenue, Suite 3104F | |
| Cleveland, Ohio 44114 | |
| T. 877-711-4769 | |
| F. 860-201-1846 | |
| 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)
Predicate Devices:
| Device Trade Name | Manufacturer |
|---|---|
| Capillus272 Pro – K143199 | Capillus, LLC |
| Theradome LH 80 Pro – K113097 | Theradome, Inc. |
| Reference Devices: | |
| Hairmax Lasercomb - K142573 | Lexington Inter |
Date Prepared: July 16, 2015 Revised 。
『
rnational
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Intended Use / Indications for Use
The LCPro and LCElite are indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I - II and Fitzpatrick Classification of Skin Phototypes I to IV.
Technological Characteristics
The LCPro consists of 224 red, visible-light, pulsed-emission diode lasers operating at 650 nanometers, that are configured within a protective inner liner and outer helmet. The LCElite is physically similar to the LCPro, except that it is configured with 80 red, visible-light, continuous-emission diode lasers, also operating at 650 nanometers and also configured within a protective inner liner and outer helmet. The use of these specific number of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. 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 reestablished. 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 Lithium Ion battery cells assembled into a proprietary battery pack. Both the battery cells pack and charger are fully compliant to recognized, international standards.
5
Performance Data:
No Clinical trial data for LCPro and LCElite were submitted for this 510(k). The LCPro and LCElite were tested for standards conformance with IEC 60825-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133.
Substantial Equivalence
The LCPro and LCElite utilize the same technological characteristics as the predicate devices. The LCPro uses the same pulsing characteristics for its laser diodes as the K143199 (Capillus272 Pro) device, and provides similar energy and irradiance output to the treatment area as this predicate. The LCElite uses continuous-output laser diodes as the K113097 (Theradome LH80 Pro) device does, and provides similar energy and irradiance output to the treatment area as this predicate The LCPro contains 224 lasers and the LCElite contains 80. The target audience of these devices is the same. The two offerings are presented to offer the prescribing physician an economic alternative for his patients.
The LCPro and LCElite are designed to provide low-level-laser therapy. Both predicate devices and the proposed devices use red light diode lasers. The sponsor believes that the differences between the subject devices of this 510(k) compared with the predicate devices, do not substantially affect the therapeutic value or the safety profile. There are differences in the physical appearances of the LCPro and LCElite, compared to the predicates.
Conclusion
The LCPro and LCElite utilize the same technological characteristics as the predicate devices listed above, and are to be used for the same intended use. The sponsor believes that there are no new types of safety and effectiveness questions for the LCPro and LCElite when compared with
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the predicate devices, and therefore that the devices should be considered substantially equivalent to the predicate devices.