(90 days)
Not Found
No
The device description and performance studies focus on low-level laser therapy and usability, with no mention of AI or ML.
Yes
The device is intended to treat Androgenetic Alopecia and promote hair growth, which are medical conditions, and it uses low-level laser therapy (LLLT) to achieve these therapeutic effects.
No
The device is intended to treat hair loss and promote hair growth, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease state.
No
The device description explicitly states that the devices contain 272 red, visible light, diode lasers configured within a cap or mounted on a stand, indicating a significant hardware component.
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 therapy (LLLT) device that delivers non-thermal energy to hair follicles. This is a physical treatment, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The capability of the average "retail customer" to self-select and appropriately use the subject device without the counsel of a health care provider was evaluated in a usability study. The study was conducted on 40 subjects of both genders, with a wide range in age, educational background, and disease status, as a sample of the intended use population. The first part of the study evaluated the ability of the subjects to decide if they were an appropriate user based on the indications and contraindications listed on the packaging. The second part assessed the ability of the subjects to understand the instructions for use, warnings, and precautions provided inside a standard retail package. An observer evaluated the ability of the subjects to properly use the device according to the instructions provided. To demonstrate equivalence for OTC distribution, a minimum of an 80% success rate was required. For each part of the test, all questions had to be answered correctly in order to pass. The results of each part were considered independently. With a passing rate of 80% for self-selection, 82.5% for the comprehension of the instructions, and 80% for the proper use of the results of the usability testing demonstrate that the SuperGrow 272 and the Ultimate 272 are safe for over-the-counter distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passing rate for self-selection: 80%
Passing rate for comprehension of instructions: 82.5%
Passing rate for proper use: 80%
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.
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 15, 2018
Super Grow Lasers % Ms. Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn Street San Diego, California 92104
Re: K181308
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: May 15, 2018 Received: May 17, 2018
Dear Ms. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
David Krause -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) K181308
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Supergrow Lasers. The logo consists of a red icon on the left and the text "SUPERGROW LASERS" on the right. The icon is made up of three red shapes. The text is in a bold, sans-serif font.
510(k) Summary K181308
DATE PREPARED
August 10, 2018
MANUFACTURER AND 510(k) OWNER
Super Grow Lasers 1903 Commonwealth #16, Houston, TX 77006, U.S.A. Telephone: Official Contact: Jeffrey 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 Email: akomiyama@acknowledge-rs.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | SuperGrow 272 and Ultimate 272 |
|---|---|
| Common Name: | Laser, Comb, Hair |
| Regulation Number: | 21 CFR 890.5500 |
| Class: | II |
| Product Code: | OAP |
| Premarket Review: | ODE/DSD/General Surgery Devices Branch One (GSDB1) |
| Review Panel: | General and Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
The SuperGrow 272 and the Ultimate 272 are substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K172982 | SuperGrow 272 and Ultimate 272 / Super Grow Lasers | ✓ |
| K163170 | Capillus272Pro, Capillus 272 OfficePro / Capillus, LLC. |
The predicate devices have not been subject to a design related recall.
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
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asers
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.
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-1, II-2, or frontal; both with Fitzpatrick Skin Types I to IV.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
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 identical designs and dimensions, and use identical materials as the devices cleared in K172982. The subject devices have intended use and identical or similar technological characteristics (laser wavelength, amount of diodes, energy per diode, output mode) as the devices cleared in K172982 and K163170. The only difference between the subject devices and those cleared in K172982 is that the indications are being expanded to include over-the-counter use (similar to the indications for the devices cleared in K163170).
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 was evaluated per IEC 60601-1, IEC60601-1-2 and IEC 60601-1-11. Biocompatibility was evaluated per ISO 10993-1.
CLINICAL TESTING
The capability of the average "retail customer" to self-select and appropriately use the subject device without the counsel of a health care provider was evaluated in a usability study. The study was conducted on 40 subjects of both genders, with a wide range in age, educational background, and disease status, as a sample of the intended use population. The first part of the study evaluated the ability of the subjects to decide if they were an appropriate user based on the indications and contraindications listed on the packaging. The second part assessed the ability of the subjects to understand the instructions for use, warnings, and precautions
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Image /page/5/Picture/1 description: The image shows the logo for Supergrow Lasers. The logo consists of a red graphic on the left and the text "SUPERGROW LASERS" on the right. The graphic is made up of three red shapes that are arranged in a triangular pattern. The text is in a bold, sans-serif font.
provided inside a standard retail package. An observer evaluated the ability of the subjects to properly use the device according to the instructions provided. To demonstrate equivalence for OTC distribution, a minimum of an 80% success rate was required. For each part of the test, all questions had to be answered correctly in order to pass. The results of each part were considered independently. With a passing rate of 80% for self-selection, 82.5% for the comprehension of the instructions, and 80% for the proper use of the results of the usability testing demonstrate that the SuperGrow 272 and the Ultimate 272 are safe for overthe-counter distribution.
CONCLUSION
Based on the testing performed, including usability testing, it can be concluded that the subject devices do not raise new issues of safety or effectiveness compared to the predicate devices. The similar or identical 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 device