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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Shapiro MD, Model Laser 272, a low-level laser therapy (LLLT) device intended to promote hair growth. However, it's crucial to understand that this submission does not involve clinical performance studies or the establishment of ground truth as would be typical for an AI/ML device.

The core of this submission is a claim of substantial equivalence to a previously cleared predicate device (Diode Laser Cap, K173678). This means the manufacturer is asserting their device is so similar to an already approved device that it does not require new clinical data to prove its safety and effectiveness.

Therefore, many of the requested elements for describing "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of an AI/ML device are not applicable to this 510(k) submission. There is no AI/ML component described, and no performance study was conducted to demonstrate efficacy of the new device itself.

Based on the provided text, here's an analysis addressing the requested points where applicable, and explaining why others are not:

1. A table of acceptance criteria and the reported device performance

Since no clinical efficacy study was conducted for this specific device, there are no "acceptance criteria" related to a performance metric like sensitivity, specificity, or accuracy that would be proven through a study. The "acceptance criteria" in this context are the criteria for demonstrating substantial equivalence to the predicate device.

Acceptance Criteria (for Substantial Equivalence):

Criterion	Shapiro MD, Model Laser 272	Diode Laser 272 (Predicate)	Result/Performance
LLLT Device Type	Laser Diode	Laser Diode	Identical
Use Application	OTC	OTC	Identical
Intended Use	Androgenic Alopecia	Androgenic Alopecia	Identical
Contains Laser Diodes	272, 5 milliwatts each	272, 5 milliwatts each	Identical
Physical Design of Device	Helmet	Helmet	Identical
Wavelength	650+/-5 NMS	650+/-5 NMS	Identical
Marketing Clearance	For females and males, OTC	For females and males, OTC	Identical
Use Type	Passive Use-Hands Free	Passive Use-Hands Free	Identical
Classification Code	OAP	OAP	Identical
Classification Name	Infrared Lamp	Infrared Lamp	Identical
Common Usage Name	Lamp, Non-Heating	Lamp, Non-Heating	Identical
Classification Panel	General & Plastic Surgery	General & Plastic Surgery	Identical
Skin Phototypes	I- IV	I- IV	Identical
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	Identical
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.	Identical
Device Class	II	II	Identical

Reported Device Performance:
The document explicitly states: "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."

Instead of clinical performance, the reported "performance" for this submission is conformance to consensus international standards:

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)
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)
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)
IEC 60825-1 Edition 2.0 2007 03 (Laser Safety & Classification)
IEC 62133 (Battery Cells) and IEC60950 (Battery Charger)

2. Sample size used for the test set and the data provenance

Sample size: Not applicable. There was no clinical test set for performance because no clinical study was conducted for this device. The "test set" for substantial equivalence was the comparison of specifications between one instance of the new device and the predicate device's specifications.
Data provenance: Not applicable for clinical performance. The data provenance for the substantial equivalence claim comes from the technical specifications of the current device and the FDA-cleared predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. No ground truth was established through expert review for clinical performance data, as no such data was generated for this submission. The "ground truth" for the substantial equivalence assertion is the detailed technical specifications of both devices.
Qualifications of experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not applicable. No clinical test set requiring adjudication was used. The substantial equivalence was asserted by the manufacturer and reviewed by the FDA.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No.
Effect size: Not applicable. This device is not an AI/ML diagnostic tool and does not involve human readers. It is a therapy device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: Not applicable. This device is a direct-to-consumer therapy device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of ground truth: Not applicable for a clinical performance study. The "ground truth" for this 510(k) submission's purpose of demonstrating substantial equivalence is the technical specifications and indications for use of the predicate device, as stated in its original 510(k) clearance.

8. The sample size for the training set

Sample size for training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Ground truth for training set: Not applicable.

In summary: The provided document is a 510(k) clearance letter for a medical device (laser hair growth device) based on substantial equivalence to a predicate device, not on new clinical performance data generated by the applicant for this specific submission. Therefore, most of the questions pertaining to testing, ground truth establishment, and AI/ML performance metrics are not relevant to this type of regulatory submission. The "study" proving it meets "acceptance criteria" here is the comparison of its technical characteristics and indications for use against a predicate device, and finding them to be identical.

Summary

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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)

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 311Chatham, 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 ContactInformation:	Stefan Galluppi –CTO, COOConversion Labs PR LLCD/B/A Shapiro MD53 Calle Palmeras, Suite 802San Juan, Puerto Rico, 00901Telephone: 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

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 malesLudwig-Savin I – II for females	Norwood-Hamilton IIa-V for malesLudwig-Savin I – II for females
Treatment Regime	16 weeks, for 30 minute treatment timesthree times a week, on alternate days.	16 weeks, for 30 minute treatment timesthree 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:

1. 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
1. 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.
1. 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.
1. IEC 60825-1 Edition 2.0 2007 03 Laser Safety & Classification
1. 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.

Regulation Number and Section

§ 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.