(85 days)
No
The document describes a low-level laser therapy device for hair growth and makes no mention of AI or ML technology in its description, intended use, or performance studies.
Yes
The device is intended to promote hair growth in individuals with androgenic alopecia, which is a medical condition, making it a therapeutic device.
No
The device is an LLLT device designed to promote hair growth. Its indications for use relate to promoting hair growth, not diagnosing a condition.
No
The device description clearly states it is a "dome-shaped low level laser therapy (LLLT) device" with "272 visible red light-emitting diodes" and is "powered by an included battery pack," indicating it is a hardware device.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Shapiro MD, Model Laser 272 is a low-level laser therapy (LLLT) device that applies light directly to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use is to promote hair growth in individuals with androgenic alopecia, which is a therapeutic application, not a diagnostic one.
Therefore, the Shapiro MD, Model Laser 272 falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenic alopecia who have Ludwig-Savin Classifications I - II, and for both, with Fitzpatrick Skin Phototypes I- IV.
Product codes
OAP
Device Description
The Shapiro MD, Model Laser 272 is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack.
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
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
No clinical performance data was submitted because the Shapiro MD, Model Laser 272 is the same device as the predicate, the Diode Laser Cap, cleared under KI 73678. The proposed device and predicate devices are IDENTICAL and the same device is offered for PRIVATE LABEL by the manufacturer. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime.
Key Metrics
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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.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 25, 2020
Conversion Labs PR LLC % Raymond R Blanche Consultant NST Consultants, Inc. 641 Shunpike Road, Suite 311 Chatham, New Jersey 07928
Re: K193667
Trade/Device Name: Shapiro MD, Model Laser 272 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: October 30, 2019 Received: December 31, 2019
Dear Raymond 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. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193667
Device Name
Shapiro MD, Model Laser 272
Indications for Use (Describe)
The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenic alopecia who have Ludwig-Savin Classifications I - II, and for both, with Fitzpatrick Skin Phototypes I- IV.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Shapiro MD, Model Laser 272
Submitter's Contact Information
| Name: | Raymond R. Blanche |
|---|---|
| Address | NST Consultants, Inc. |
| 641 Shunpike Road, Suite 311 | |
| Chatham, NJ 07928 | |
| Telephone: | (973) 539-7444 |
| Facsimile: | (973) 539-7445 |
| Name of Device and Name/Address of Sponsor | |
| Trade Name: | Shapiro MD, Model Laser 272 |
| Sponsor Contact | |
| Information: | Stefan Galluppi –CTO, COO |
| Conversion Labs PR LLC | |
| D/B/A Shapiro MD | |
| 53 Calle Palmeras, Suite 802 | |
| San Juan, Puerto Rico, 00901 | |
| Telephone: 866-351-5907 | |
| Date Prepared: | March 19, 2020 |
| 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: | Diode Laser Cap (K173678), Cosmo Far East Technology Limited |
Device Description
The Shapiro MD, Model Laser 272 is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272 visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack.
Intended Use / Indications for Use
The Shapiro MD, Model Laser 272 is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton Classifications of Ila-V, or females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and for both, with Fitzpatrick Skin Phototypes I-IV.
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Technological Characteristics
The Shapiro MD, Model Laser 272 contains the listed number of diode lasers configured within an outer cap helmet and protective inner. The use 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 Shapiro MD, Model Laser 272 is powered by a lithium-ion battery pack that contains an embedded controller chip. In all other area of design, manufacturing, and aesthetic appearance, the devices are identical, as they are private labeled by the manufacturer Cosmo Far East Technology Limited.
Performance Data:
No clinical performance data was submitted because the Shapiro MD, Model Laser 272 is the same device as the predicate, the Diode Laser Cap, cleared under KI 73678. The proposed device and predicate devices are IDENTICAL and the same device is offered for PRIVATE LABEL by the manufacturer. They are the same device in optical, electronic, mechanical function and aesthetic appearance, as well as the same recommended clinical treatment regime. The sponsor Conversion Labs PR LLC has chosen to use the identical User Manual as the manufacturer. Only the logo and color graphics have been altered. A page by pages analysis supports this use.
Substantial Equivalence
Shapiro MD, Model Laser 272 is the same device as the Diode Laser Cap, cleared under K173678, with 272 visible red light-emitting diodes at 650mm and 5mW each. Both devices have identical indications for use, treatment regiment, and technological and design characteristics, as noted below.
Treatment Protocol
The Shapiro, Model Laser 272 and the identified predicate, possess the same treatment regime of 30 minutes, every other day, on non-consecutive days, for the initial treatment regime of 16 weeks.
The following Comparison Chart in support of substantial equivalence is provided:
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| Shapiro MD, Model Laser 272 | Diode Laser 272 | |
|---|---|---|
| LLLT Device Type | Laser Diode | Laser diode |
| Use Application | OTC | OTC |
| Intended Use Androgenetic Alopecia | Androgenic Alopecia | Androgenic Alopecia |
| Contain Laser Diodes-Class 3R | 272, 5 milliwatts each. | 272, 5 milliwatts each |
| Physical Design of Device | Helmet | Helmet |
| Wavelength | 650+/-5 NMS. | 650+/-5 NMS. |
| Marketing Clearance | For females and males, OTC | For females and males, OTC |
| Use Type | Passive Use-Hands Free | Passive Use-Hands Free |
| Classification Code | OAP | OAP |
| Classification Name | Infrared Lamp | Infrared Lamp |
| Common Usage Name | Lamp, Non-Heating | Lamp, Non-Heating |
| Classification Panel | General & Plastic Surgery | General & Plastic Surgery |
| Skin Phototypes | I- IV | I- IV |
| Hair Loss Classification | Norwood-Hamilton IIa-V for males | |
| Ludwig-Savin I – II for females | Norwood-Hamilton IIa-V for males | |
| Ludwig-Savin I – II for females | ||
| Treatment Regime | 16 weeks, for 30 minute treatment times | |
| three times a week, on alternate days. | 16 weeks, for 30 minute treatment times | |
| three times a week, on alternate days. | ||
| Device Class | II | II |
Over – The – Counter Testing Program
No OTC testing was performed for this submission because the User Manual and packing for the subject device are same as in the predicate. The only exception is color and logo of the subject device literature. The graphic changes do not alter the content of the User Manual, the key variable in any OTC testing evaluation.
Non-Clinical Testing Performance
The Shapiro MD, Model Laser 272, conforms to the following international consensus standards:
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- IEC 60601-1:2005 + CORR. 1: 2006 + CORR. 2: 2007 + A1: 2012 Medical Electrical Equipment- Part 1: General Requirements for Basic Safety and Essential Performance
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- IEC 60601-1-2: 2014 Medical Electrical Equipment Part 1-2 General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements and Tests.
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- ISO 10993-5 2009 Biological Evaluation of Medical Devices Part 5 Tests for In Vitro Cytotoxicity, ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
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- IEC 60825-1 Edition 2.0 2007 03 Laser Safety & Classification
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- IEC 62133 Battery Cells and IEC60950 for the Battery Charger
Conclusion
Based on the technical comparisons between the Shapiro MD, Model Laser 272 and the identified predicate it can be concluded that the Shapiro MD, Model Laser 272 is identical to the predicate device in technical specifications. Since the Shapiro MD, Model Laser 272 is manufactured using the identical
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platform with no difference between models, it can be concluded that the Shapiro MD, Model Laser 272 is equally safe. Indications for use of the two devices are also identical. Therefore, it can be determined that the Shapiro MD, Model Laser 272 is Substantially Equivalent to the identified predicate.