(83 days)
Not Found
No
The device description focuses on the physical components and mechanism of action (LLLT) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The performance studies are focused on safety and electrical standards, not algorithmic performance.
Yes.
The device is intended to treat Androgenetic Alopecia and promote hair growth. This indicates a therapeutic intended use.
No
The device is intended to treat androgenetic alopecia and promote hair growth, not to diagnose medical conditions.
No
The device description explicitly details hardware components, including diode lasers, a cap/dome, and a power supply, indicating it is a physical 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.
- Device Description: The SuperGrow 272 and Ultimate 272 are described as non-invasive, low-level laser therapy devices that deliver energy to the scalp. They do not involve the analysis of samples taken from the body.
- Intended Use: The intended use is to treat hair loss and promote hair growth, which is a therapeutic application, not a diagnostic one.
Therefore, this device falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SuperGrow 272 laser hat and the Ultimate 272 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 SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272. In the Ultimate 272, the SuperGrow 272, is inserted into a dome attached to a stand, and is intended for in-office use.
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
The SuperGrow 272 is a cap and the Ultimate 272 is for in-office 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
No FDA performance standards have been established for the SuperGrow 272 and the Ultimate 272.
The following tests were performed to demonstrate safety based on current industry standards:
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1, IEC60601-1-2 and IEC 60601-1-11
Performance and Laser Safety: The subject device was tested in compliance to IEC 60825-1.
The results of these tests indicate that the SuperGrow 272 and the Ultimate 272 are substantially equivalent to the predicate devices.
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 shows 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, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 19, 2017
Super Grow Lasers % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn Street San Diego, California 92104
Re: K172982
Trade/Device Name: SuperGrow 272, Ultimate 272 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 26, 2017 Received: September 27, 2017
Dear Allison Komiyama:
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, 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);
1
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 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 medical devices and radiation-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 -ਟਤ
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) K172982
Device Name SuperGrow 272 - Ultimate 272
Indications for Use (Describe)
The SuperGrow 272 laser hat and the Ultimate 272 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Supergrow Lasers. The logo consists of a red abstract symbol on the left, followed by the words "SUPERGROW LASERS" in a bold, sans-serif font. The text is black and the background is light-colored.
510(k) Summary
DATE PREPARED
September 26, 2017
MANUFACTURER AND 510(k) OWNER
Super Grow Lasers 1903 Commonwealth Street #16 Houston, TX 77006, U.S.A. Telephone: Official Contact: Jeff Stanifer, CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 akomiyama@acknowledge-rs.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
SuperGrow 272 and Ultimate 272
COMMON NAME
Laser, Comb, Hair
DEVICE CLASSIFICATION
21 CFR 890.5500, Product Code OAP, Class II
PREMARKET REVIEW
ODE/DSD/ General Surgery Devices Branch One (GSDB1) General and Plastic Surgery
INDICATIONS FOR USE
The SuperGrow 272 laser hat and the Ultimate 272 are intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood – Hamilton Classifications of Ila 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.
4
Image /page/4/Picture/1 description: The image shows the logo for Supergrow Lasers. The logo consists of a red abstract symbol on the left, followed by the text "SUPERGROW LASERS" in a bold, sans-serif font. The text is black and slightly stylized, giving it a modern and technological appearance.
DEVICE DESCRIPTION
The SuperGrow 272 and the Ultimate 272 are non-invasive, low level laser therapy (LLLT) devices each containing 272 red, visible light, diode lasers. The devices are designed to deliver non-thermal energy to the hair follicles via photostimulation of the scalp. The SuperGrow 272 consists of 272 red, visible light, diode lasers operating at a 650 nanometer wavelength (maximum output power of each is 5 mW). The diodes are configured within a cap, enclosed between the outer shell and inner liner, both made of polyethylene terephthalate (PET). The Ultimate 272 is exactly the same as the SuperGrow 272 in every way except it is mounted on a stand. The same electrical design (power supply and the on/off switch) has been applied to the Ultimate 272. In the Ultimate 272, the SuperGrow 272, is inserted into a dome attached to a stand, and is intended for in-office use.
PREDICATE DEVICE IDENTIFICATION
The SuperGrow 272 and Ultimate 272 are substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K163170 | Capillus272Pro, Capillus 272 OfficePro / Capillus, LLC. | ✓ |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the SuperGrow 272 and the Ultimate 272. The following tests were performed to demonstrate safety based on current industry standards:
Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to IEC 60601-1, IEC60601-1-2 and IEC 60601-1-11
Performance and Laser Safety: The subject device was tested in compliance to IEC 60825-1.
The results of these tests indicate that the SuperGrow 272 and the Ultimate 272 are substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
SuperGrow Lasers believes that the SuperGrow 272 and the Ultimate 272 are substantially equivalent to the predicate devices based on the information summarized here:
The subject devices have similar designs and dimensions, and use similar materials as the devices cleared in K163170. The subject devices have intended use and similar technological characteristics (laser wavelength, amount of diodes, energy per diode, output mode) to the devices cleared in K163170. Any differences in technological characteristics (power source) do not raise different questions of safety and effectiveness. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.
5
Image /page/5/Picture/1 description: The image shows the logo for Supergrow Lasers. The logo consists of a stylized red symbol on the left, followed by the text "SUPERGROW LASERS" in a bold, sans-serif font. The text is black and appears to be slightly italicized.
CONCLUSION
Based on the testing performed, including laser safety, electromagnetic compatibility, and electrical safety, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed SuperGrow 272 and Ultimate 272 are assessed to be substantially equivalent to the predicate devices. The devices are considered safe and effective for their intended use.