SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM by INOLASE 2002, LTD.

The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

Device Description

The Serenity PSF™ (Pneumatic Skin Flattening) System is a device which has the ability to produce a vacuum at a level of 200-700 mmHg. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PFS system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.

AI/ML Overview

This 510(k) summary (K062589) describes the Serenity PSF™ (Pneumatic Skin Flattening) System, an accessory to compatible laser or Intense Pulsed Light (IPL) systems for hair removal. The document focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating direct performance against such criteria.

Therefore, the requested information cannot be fully extracted from the provided text. However, based on the context of a 510(k) submission, we can infer some general aspects and state what is not present:

Missing Information:
The provided document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets.
Data provenance (country of origin, retrospective/prospective).
Number and qualifications of experts for ground truth.
Adjudication method for the test set.
Results from a multi-reader multi-case (MRMC) comparative effectiveness study, nor an effect size for human reader improvement with AI.
Details on a standalone (algorithm only) performance study.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Analysis based on available information:

The document is a 510(k) summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically focuses on comparing technological characteristics, intended use, and safety/effectiveness rather than presenting a performance study against predefined acceptance criteria for a novel algorithm's accuracy or efficacy.

Here's an attempt to answer the questions based on the limited information, primarily noting what is not provided:

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

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (as per document)
Safety: Device operates safely within specified parameters (e.g., vacuum levels).	"Substantially equivalent" to predicate device in technology and intended use, implying comparable safety profile.
Functionality: Produces vacuum (negative pressure) of 200-700 mmHg and flattens skin.	"produces a vacuum at a level of 200-700 mmHg." "negative pressure results in the flattening of the skin of the treatment site."
Compatibility: Functions as an accessory with legally marketed Laser or IPL systems.	"accessory for a compatible legally market Laser or Intense Pulse Light System."
Intended Use: Used for hair removal by enhancing light penetration and reducing erythema.	"for use in hair removal." "expels blood from the treatment site which enhances the light penetration... as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema."

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

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document.

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 specified. This document does not describe a study involving expert-established ground truth for a test set.

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

Not specified. There is no mention of a test set requiring adjudication in this document.

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

No. The device is a pneumatic accessory for laser/IPL therapy, not an AI-assisted diagnostic or interpretative system. Therefore, an MRMC study comparing human readers with/without AI assistance is not applicable and not mentioned.

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

No. This device is a physical accessory, not an algorithm, so a standalone algorithm performance study is not applicable.

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

Not applicable in the context of an algorithm's "ground truth." The document describes the physical and functional aspects of the device in relation to its intended use (skin flattening, enhanced light penetration, reduced erythema for hair removal). Performance is gauged by these physical effects and the established safety of similar predicate devices.

8. The sample size for the training set

Not applicable. As a physical device accessory, there is no "training set" in the sense of machine learning.

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

Not applicable, as there is no training set for an algorithm. The "ground truth" for the device's claims would be based on engineering specifications, physical testing, and potentially clinical observation of its effects (skin flattening, blood expulsion, etc.) in a clinical setting, but these details are not provided beyond the functional description.

Summary

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510(k) Summarv

K 062589

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

1. (a) Submitter's George J. Hattub Address: MedicSense, USA 291 Hillside Avenue Somerset, MA 02726 NOV 3 U 2006 1. (b) Manufacturer Inolase 2002, Ltd. Address: 13 Giborei Israel St., PO Box 8497 Netanya (New Industrial Area) Israel, 42504 Mfg. Phone: 972-9-865-6750 Raphi Shavit, CEO Contact Person: Date: Revised- November 12, 2006 2. Device & Laser Handpiece Accessory System (Class 2), Product Code GEX, Classification Name: 21 CFR 878.4810 - Tradename of device: Serenity PSF™ (Pneumatic Skin Flattening) System Aesthera AlP™ Intense Pulsed Light System (K041554) Predicate Device: 3. The Serenity PSF™ (Pneumatic Skin Flattening) System is a device which has the 4. Description: ability to produce a vacuum at a level of 200-700 mmHg. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PFS system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema. The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a 5. Intended Use: compatible legally market Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface just prior to the administration of the treatment beam through it. 6. Comparison of Technological With respect to technology, the Serenity PSF™ (Pneumatic Skin Flattening) System Characteristics: is substantially equivalent to one of its predicate device in that it produces a pneumatic connection of the treatment site for the delivery of photonic treatment. When the PSF™ System is used in combination with a legally marketed device such as an IPL system, it also has the same basic intended use as this predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Inolase 2002, Ltd. % MedicSense, USA Mr. George J. Hattub, RAC & CQE Senior Staff Consultant 291 Hillside Avenue Somerset, Massachusetts 02726

NOV 3 0 2006

Re: K062589

Trade/Device Name: Serenity PSF™ (Pneumatic Skin Flattening) System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 21, 2006 Received: September 25, 2006

Dear Mr. Hattub:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Mr. George J. Hattub, RAC & CQE

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of the (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w yours of substantial equivalence of your device of your device to a legally prematics notification. The stassification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acc (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K 06 25 8-9

Device Name: Serenity PSF™ (Pneumatic Skin Flattening) System

Indications For Use: The Serenity PSF™ (Pneumatic Skin Flattening) System is an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

(revised 11/12/06)

Prescription Use ﻨﮯ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices

16062559 510(k) Number_

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.