(26 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, which are medical conditions that a therapeutic device would address.
No
The device is described as a low-level laser device intended to promote hair growth in individuals with Androgenetic Alopecia; it does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "hand-held low level laser device" and describes physical components like "comb teeth," indicating it is a hardware device, not software-only.
No, 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.
- Device function: The HairMax LaserComb devices are external, hand-held devices that apply laser light directly to the scalp. They do not analyze samples taken from the body.
- Intended Use: The intended use is to treat Androgenetic Alopecia and promote hair growth by interacting with the scalp tissue, not by analyzing biological samples.
Therefore, based on the provided information, the HairMax LaserComb Advanced 7 and Pro 12 are not IVDs. They are therapeutic devices that use light energy.
N/A
Intended Use / Indications for Use
The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.
The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.
Product codes
OAP
Device Description
Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Nonclinical Testing
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10. The HairMax Advanced 7 and Pro 12 were subject to the same preclinical requirements as the predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
HairMax Lux 9 K110233
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
SEP 2 6 2011
6. 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for Lexington International, LLC HairMax LaserComb Lux 9 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
- Lexington International, LLC Sponsor: 777 Yamato Rd. Suite 105 Boca Raton, FL 33431 (561) 417-0200 research@hairmax.com Establishment Registration Number: 3006182775
- Olsson Frank Weeda Contact: C/O Casper E Uldriks Esq. 1400 Sixteenth Street, NW Washington DC 20036
August 30, 2011 Date:
Proprietary Name: HairMax LaserComb
Common or Usual Name: Lamp, nonheating, for promotion of hair growth.
Product Code: OAP
Classification Name: 21 CFR 890.5500 Infrared lamp
Predicate Device: HairMax Lux 9 K110233
Device Description:
Similar to the HairMax Lux 9 K110233, the modified HairMax Advanced 7 and Pro 12 consist of a hand-held low level laser device that emits laser light with the intention to promote hair growth. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp.
Intended Use / Indications for Use
The HairMax LaserComb Advanced 7 is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.
1
The HairMax LaserComb Pro 12 is indicated to treat Androgenetic Alopecia and promote hair growth in females with who have Ludwig-Savin Scale 1-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV.
Technological Characteristics
The modifications to the HairMax Lux 9 since its previous clearance in K110233 do not alter the safety of the device. The predicate device contains 9 laser modules. The modified devices use the exact same laser modules and hair parting teeth mechanism. The difference in the predicate versus modified device is the quantity of the laser modules. The Advanced 7 contains 7 laser modules and the Pro 12 contains 12 laser modules. Adjustments in treatment time compensate for the different number of laser modules.
Nonclinical Testing
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10. The HairMax Advanced 7 and Pro 12 were subject to the same preclinical requirements as the predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.
Substantial Equivalence
The Advanced 7 and Pro 12 are as safe and effective as the predicate device, HairMax Lux 9. The subject devices have the same intended use of affecting hair growth as the predicate device. The subject devices have indications, i.e., treating androgenetic alopecia, and the same specific indication of promoting hair growth in females, who have Ludwig-Savin Scale I-4, II-1, II-2 or frontal and Fitzpatrick Skin Types I to IV, as the predicate device.
The Advanced 7 and Pro 12 are identical in technological characteristics as the device cleared in K110233, including its laser power, wavelength, laser delivery method, its comb component, its instructions for use and its audible timer. The changes in the number of laser modules does not change the safety or effectiveness.
2
Conclusion:
The Advanced 7 and Pro 12 have the following similarities to the HairMax Lux 9:
- has the same indicated use, ●
- same identical laser modules .
- . same hair parting teeth
- uses the same operating principle .
- incorporates the same basic device design and physical properties .
- incorporates the same materials .
Therefore the modification to the Lux 9 can be found substantially equivalent to the HairMax LaserComb cleared in K110233.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized emblem featuring three abstract shapes, possibly representing human figures or elements of health and well-being. The emblem is simple and modern in design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-Ci609 Silver Spring, MD 20993-0002
Lexington International, LLC % Olsson Frank Weeda Casper E Uldriks, Esq. 1400 16th Street Northwest. Suite 400 Washington, District of Columbia 20036
SEP 26. 2011
Re: K112524
Trade/Device Name: HairMax Advanced 7, HairMax Professional 12 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared lamp Regulatory Class: Il Product Code: OAP Dated: September 16, 2011 Received: September 19, 2011
Dear Mr. Uldriks:
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
4
Page 2 - Casper E Uldriks, Esq.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/medicaldevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
5. Indications for Use
510(k) Number (if known): K (12524
Device Name: HairMax Advanced 7, HairMax Professional 12
Indications for Use:
The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal and Fitzpatrick Skin Types I to IV.
The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal and Fitzpatrick Skin Types I to IV.
Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RP Ogle for nuxen
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112524