The no!no! Skin™ is intended to provide phototherapeutic light and heat to the body and is generally indicated to treat dermatological conditions. It is specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Device Description

The no!no! Skin™ device is an over the counter device employing LHE® (Light & Heat Energy) phototherapy as a part of its fundamental characteristics to treat acne. It is a small, light, hand-held, portable, battery powered devices designed to treat individual acne pimples. The no!no! Skin™ device consist of an enclosure, a rechargeable battery, an electronic circuit and a low voltage halogen lamp. The treatment tip diameter of 8 mm covers an area of 0.5 cm². The energy delivered to the lesion is a combination of focused light emitted from the halogen lamp together and the heat accumulated in the tip placed over the acne lesion.

AI/ML Overview

The provided document is a 510(k) summary for the Radiancy Ltd. no!no! Skin™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and intended use. Crucially, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Instead, the document states:

"A series of safety and performance testing were performed to demonstrate that the modified no!no! Skin™ did not raise any new questions of safety and efficacy."
These tests included: "Electrical Safety testing" and "Temperature Evaluation test."
"Based on the risk analysis performed and these tests results, Radiancy Ltd. believes that the modified no!no! Skin™ device is substantially equivalent to the cleared no!no! Skin™ device and does not raise any new safety and/or effectiveness issues."

This indicates that the submission relies on demonstrating that changes made to an already cleared device (K082423) did not negatively impact its safety and effectiveness, rather than providing a de novo study with acceptance criteria and performance results for the device's clinical efficacy.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's a breakdown of what can be answered and what cannot:

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

Not available. The document states safety and performance tests were done (electrical safety, temperature evaluation) but does not provide specific acceptance criteria or reported performance results in a table format for these tests, nor for clinical efficacy. The submission focuses on substantial equivalence based on not raising new questions of safety and efficacy with changes made to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document does not describe a clinical study with a test set of human subjects, therefore, sample size and data provenance are not mentioned in this context. The "tests" mentioned are technical safety and performance tests of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not available. Since there is no described clinical study involving a test set of patients or medical images requiring ground truth establishment by experts, this information is not present.

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

Not applicable/Not available. No clinical study with a test set requiring adjudication is described.

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

Not applicable/Not available. The device is not an AI-assisted diagnostic tool or an imaging device. It's a phototherapy device for acne. Therefore, an MRMC study is irrelevant in this context and none was performed or described.

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

Not applicable/Not available. Again, this is a physical medical device, not an algorithm. Its performance is inherent in its operation and effect on the user/patient.

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

Not applicable/Not available. No clinical efficacy study with ground truth for patient outcomes is described. The "tests" were likely engineering or bench tests for electrical and thermal safety.

8. The sample size for the training set

Not applicable/Not available. As this is not an AI/machine learning device, there is no concept of a "training set."

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

Not applicable/Not available. As above, no training set exists for this device.

Summary

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510(K) SUMMARY Radiancy Ltd. no!no! Skin™

4 2010

K102477

7.1.1 Applicant's Name:

Radiancy Ltd. 5 Hanagar Street Hod Hasharon 45240, Israel Tel: +972 (9) 775-7500 Fax: +972 (9) 775-7511

7.1.2 Contact Person:	Dr. Rothman Julia
	5 Hanagar Street
	Hod Hasharon 45240, Israel
	Tel: +972-9-775-7539
	Fax: +972-9-775-7511
	Julia@radiancy.com

7.1.3 Date Prepared: August 18, 2010
no!no! Skin™ 7.1.4 Trade Name:
7.1.5 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

cleared under K082423.

7.1.6 Classification:	Class II; Product Code GEX;Regulation No. 878.4810Panel: General and Plastic Surgery Devices
7.1.7 Predicate Devices:	Radiancy Ltd. no!no! Skin™ device

7.1.8 Device Description:

7-4

Confidential and Proprietary Information Radiancy no!no! Skin" Special 510(K) Submission Section 7 -- Administrative Requirements

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The no!no! Skin™ device consist of an enclosure, a rechargeable battery, an electronic circuit and a low voltage halogen lamp. The treatment tip diameter of 8 mm covers an area of 0.5 cm². The energy delivered to the lesion is a combination of focused light emitted from the halogen lamp together and the heat accumulated in the tip placed over the acne lesion. ·

The user performs the treatment by placing the treatment tip over the lesion and pressing the ON push button to activate one treatment cycle. During the 10 seconds treatment cycle, flashes of light may be seen through the treatment tip. An audio signal indicates the end of the treatment cycle. The device is then removed from the skin, while a green LED flashes for a few seconds, indicating the cool-down period for both the device and the skin. When the flashing stops and a green light appears, the device is ready to deliver another treatment cycle of pulses to the same lesion. The process can then be repeated on another lesion. A second treatment session (consisting of two treatment passes per lesion) may be delivered 6 - 12 hours later.

The user can stop the treatment by pressing the ON button any time during the treatment. Following the conclusion of the treatment session, the device is recharged, using the charger provided with the system. A light indicates that the recharging process is complete, and that the device is 'Ready to Treat'.

7.1.9 Intended Use:

7.1.10 Performance Standards:

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

7.1.12 Performance Data & Substantial Equivalence

The no!no! Skin™ is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the Radiancy Ltd.'s commercially available no!no! Skin™ device cleared under K082423.

The principle changes between the devices include:

= Annular Cooling Ring (TEC=Thermo electric cooling) =TEC was added around the treatment tip to give a more pleasant sensation during treatment.
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Confidential and Proprietary Information Radiancy no!no! Skin" Special 510(K) Submission Section 7 - Administrative Requirements

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· Indication Wording was edited to better represent LHE technology.
· Battery Change higher energy type was used to facilitate cooling without increasing the physical dimensions and weight of the device.

A series of safety and performance testing were performed to demonstrate that the modified no!no! Skin™ did not raise any new questions of safety and efficacy. These tests included:

Electrical Safety testing 트
. Temperature Evaluation test

Based on the risk analysis performed and these tests results, Radiancy Ltd. believes that the modified no!no! Skin™ device is substantially equivalent to the cleared no!no! Skin™ device and does not raise any new safety and/or effectiveness issues.

Confidential and Proprietary Information
Radiancy no!no! Skin™ Special 510(K) Submission Section 7 - Administrative Requirements

7-6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its wings are curved upwards. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

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

4 2010 OCT

Radiancy Ltd. % Dr. Julia Rothman Clinical Director 5 Hanagar Street Hod Hasharon 45240, Israel

Re: K102477

Trade/Device Name: No! No! Skin™ 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: OLP Dated: September 26, 2010 Received: September 29, 2010

Dear Dr. Rothman:

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.

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Page 2 - Dr. Julia Rothman

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address 'http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K102477

no!no! Skin™M Device Name:

Indicațions for Use:

Prescription Use (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use 2 (Part 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilkeda for man

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102477

7-10

Confidential and Proprietary Information
Radiancy no!no! Skin™ Special 510(K) Submission Section 7 – Administrative Requirements

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.