The NIRA Beauty Skincare Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging).

AI/ML Overview

1. Acceptance Criteria and Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a structured format. However, based on the efficacy section, the key performance indicator and the reported result can be extracted:

Acceptance Criteria (Implied)	Reported Device Performance
Significant reduction in periorbital wrinkles (clinical endpoint)	Median reduction of 1 unit in the FWS (Facial Wrinkle Scale)
Percentage of subjects showing overall wrinkle improvement	69% of subjects showed at least one score improvement on overall facial wrinkles assessment
Maintenance of wrinkle improvement post-treatment	68% of users with wrinkle reduction maintained some improvement for at least 3 months after stopping use
Safety Profile	No unanticipated or severe adverse events; common adverse events (skin warmth, stinging, dryness, temporary skin color changes) were not unexpected.

2. Sample Size for the Test Set and Data Provenance:

Sample Size: 76 subjects.
Data Provenance: The study was a "76 subject, open-label comparison to baseline effectiveness, and safety study." While the specific country of origin is not stated, the manufacturer (Dermal Photonics Corporation) is based in Massachusetts, USA, suggesting the study likely took place in the US. The study is prospective as it's a comparison to baseline effectiveness and safety.

3. Number of Experts and Qualifications:

The document does not specify the number of experts used to establish ground truth or their qualifications. The efficacy assessment mentions "median reduction of 1 unit in the FWS" and "overall facial wrinkles assessment," but it's not explicitly stated if this assessment was performed by independent, qualified experts.

4. Adjudication Method:

The document does not mention any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The study described is a clinical study on the device's efficacy and safety rather than a comparison of human readers with and without AI assistance.

6. Standalone Performance:

Yes, the study primarily describes the standalone performance of the device (NIRA Beauty Skincare Laser) as used by subjects. The clinical study assessed the device's effectiveness when used by individuals, without explicit mention of human-in-the-loop performance with an AI component.

7. Type of Ground Truth Used:

The ground truth appears to be based on clinical assessment/subjective evaluation of wrinkle reduction, likely by clinicians or trained personnel using a scoring system like the Facial Wrinkle Scale (FWS), combined with subjective reports of safety from the subjects. It is not explicitly stated if objective measures beyond a scoring scale were used.

8. Sample Size for the Training Set:

The document describes a clinical study for the device's efficacy and safety. There is no mention of a separate "training set" in the context of an algorithm or AI model. The 76-subject clinical study serves as the primary data for demonstrating the device's performance for regulatory purposes.

9. How the Ground Truth for the Training Set Was Established:

As there is no explicit mention of a training set for an algorithm, this question is not directly applicable. For the clinical study that serves as performance data, the "ground truth" (i.e., wrinkle reduction and safety outcomes) was established through direct clinical assessments and subject reporting, as described in point 7.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 12, 2017

Dermal Photonics Corporation Mr. David Bean CEO 5 Elm St. Suite 10 Danvers, Massachusetts 01923

Re: K163137

Trade/Device Name: Nira Beauty Skin Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS Dated: June 8, 2017 Received: June 12, 2017

Dear Mr. Bean:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Jennifer R. Stevenson -S3

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) K163137

Device Name NIRA Beauty Skin Laser

Indications for Use (Describe)	The NIRA Beauty Skin Laser is indicated for the treatment of periorbital wrinkles.
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Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary as required by 21 CFR 807.92(a)

Dermal Photonics A) Submitted by: 5 Elm Street, Suite 10 Danvers, MA 01923
Official Contact: David Bean CEO dbean@dermalphotonics.com (781) 451-1701

B) Classification Names: Light based Over the Counter Wrinkle Reduction

Proprietary Name:	NIRA Beauty Skincare Laser
Device Class:	Class II
Regulations	21 CFR 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Codes:	OHS
Classification panel:	General & Plastic Surgery
C) Primary Predicate:	K090525 Palomar LOI System
D) Date Prepared:	April 27, 2017

E) Device Description:

E) Intended Use/Indications For Use:

The NIRA Beauty Skincare Laser is indicated for the treatment of periorbital wrinkles.

F) Substantial Equivalence Comparison and Discussion

	Dermal PhotonicsNIRA Beauty Skincare LaserK163137	PalomarLOI SystemK090525
Productcode	OHS	ONG

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	Dermal PhotonicsNIRA Beauty Skincare LaserK163137	PalomarLOI System
		K090525
Indicationsfor Use	The NIRA Laser is indicated for thetreatment of periorbital wrinkles.	The LOI System is an over-the-counterdevice intended for treatment ofperiorbital wrinkles.
OTC	Yes	Yes

Similarities

The NIRA Laser has similar indications for use, is an OTC device and uses a similar wavelength as the predicate device.

The NIRA Laser has similar clinical efficacy three (3) months after users stopped using NIRA, similar to the Palomar LOI System.

Like the predicate device, the NIRA Laser meets all electrical, EMC, or Laser, and FCC testing requirements.

Differences

Differences between the NIRA Laser and the predicate devices include:

Pulse/treatment duration ●
Treatment schedules

Conclusion

Differences between the NIRA Laser and the predicate device do not raise different issues of safety or effectiveness. The NIRA Laser was demonstrated in a clinical study to be safe and effective and meet its indication for use. The NIRA Laser is substantially equivalent to the predicate devices.

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G) Performance Testing

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.

Bench

The NIRA Laser meets all electrical, EMC, or Laser, and FCC testing requirements. Software documentation was provided consistent with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11. 2005 and a Moderate Level of Concern

Human – Self Selection and Usability

A Self-selection study successfully assessed whether or not naive laypersons could correctly determine (self-select) if they are appropriate candidates for use of the NIRA device based solely on reading the box labeling.

A Usability study successfully assessed that the NIRA Laser is usable by the device's intended users in a simulated use environment.

Human – Clinical

A clinical study was conducted. The clinical study for periorbital wrinkles was a 76 subject, open-label comparison to baseline effectiveness, and safety study.

Efficacv

Periorbital treatment met its predefined clinical and statistical endpoint with a median reduction of 1 unit in the FWS. An improvement of at least one score was seen in 69% of subjects on overall facial wrinkles assessment.68% of users who achieved wrinkle reduction of 1 full scale unit maintained some wrinkle improvement for at least 3 months after users stopped using NIRA.

Safety

No unanticipated or severe adverse events were reported. Adverse events reported included skin warmth and stinging, dryness, and temporary skin color changes where skin became darker in color. These were not unexpected.

H) Consensus Standards

The NIRA Beauty Skincare Laser complies with the following standards:

ETSI EN 300 440-2 v1.4.1 (2010-08): Electromagnetic compatibility and Radio spectrum . Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
ETSI EN 301 489-1 v1.9.2 (2011-09) Electromagnetic compatibility and Radio spectrum ● Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
ETSI EN 301 489-3 v1.6.1 (2002-08) Electromagnetic compatibility and Radio spectrum ● Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and

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services: Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz

IEC 60601-1-2:2007 (Third Edition) Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
AAMI ANSI ES 60601-1:2005(R)2012 and A1:2012. C1:2009/(R)2012 and . A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11: 2010 Medical electrical equipment Part 1-11: General requirements . for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
. IEC 60355-1: 2010 Household and similar electrical appliances - Safety - Part 1: General requirements
IEC 60355-2-23:2008 Household and similar electrical appliances Safety Part 2-23: . Particular requirements for appliances for skin or hair care
IEC 60825-1: 2007 Safety of laser products Part 1: Equipment classification and ● requirements
. ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems
IEC 62366 (First Edition) + A1:2014 Medical devices -- Part 1: Application of usability engineering to medical devices
IEC 60601-1-6: 2010 (Third Edition) +A1;2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
AAMI ANSI HE75: 2009/(R) 2013 Human factors engineering Design of medical ● devices

Conclusion

The NIRA Laser is substantially equivalent to the predicate devices. Clinical data demonstrate that the NIRA Laser is safe and effective, and meets its indications for use.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.