The intense pulsed light therapy system is indicated for use in surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690-1200nm.

Device Description

The IPL Therapy Systems is an Intense Pulsed Light Therapy System which delivers intense pulsed light at a wavelength ranging from 690nm -1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is causing thermal damage to target chromophores by using light of appropriated wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL Therapy System is different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. The Sincoheren IPL Therapy system controlled by computer is composed: - Main unit - LCD monitor - Treatment handle . The embedded microprocessor monitors can control the system continually. The operating Interface includes a full-LCD screen (8.0 inch), the key switch and emergency shut-off knob. LCD screen both shows the system work program, treatment parameters and number of light emitting. The treatment handle operated by hand comprises the intense emitter and transmission system.

AI/ML Overview

The provided document is a 510(k) summary for an Intense Pulsed Light Therapy System. It states that no clinical studies were required to support substantial equivalence. Therefore, it does not contain the information needed to answer many of the questions regarding acceptance criteria, study details, and performance.

However, based on the information provided, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or reported device performance metrics are provided in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from clinical trials.

The "Indications for Use" section (page 6) does list "Density" (energy density in J/cm²) and "Program" settings for hair removal across different skin types (I-V, with N/A for VI). However, these are operational parameters, not performance metrics or acceptance criteria.

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

Not applicable. No clinical test set was used for this submission. The device did not require clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No clinical studies were performed, and thus no ground truth was established by experts for a test set.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

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

Not applicable. No clinical studies were done, so no MRMC study with or without AI assistance was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Not applicable. This device is a medical device (IPL system) operated by a human, not an AI algorithm. Its performance is tied to the operator and the device's physical parameters.

7. Type of Ground Truth Used

Not applicable. No clinical studies were performed. The "ground truth" for this 510(k) submission primarily relies on the equivalency of its non-clinical specifications and intended use to a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. This is a hardware medical device; it does not involve machine learning or a "training set" in the computational sense. The "development" aspects mentioned (Risk Analysis, Requirements Reviews, Design Reviews, etc.) refer to engineering and quality assurance processes, not AI model training.

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

Not applicable. As above, there is no training set for this type of device.

Summary of Device's Basis for Approval (from the document):

The device's approval is based on:

Substantial Equivalence: The manufacturer asserts that the Intense Pulsed Light Therapy System is "as safe, as effective, and performance is substantially equivalent to the predicate device(s)" (K093627 IPLUSELIGHT IPL SYSTEM).
Non-Clinical Tests: Compliance with voluntary standards (IEC 60601-1, IEC 60601-1-2) and internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, raw materials verification, unit/module verification, integration testing, final acceptance testing, performance testing, safety testing).
No Clinical Studies Required: "The subject of this premarket submission, Intense Pulsed Light Therapy System, did not require clinical studies to support substantial equivalence."

Summary

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FEB 1 1 2013

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

123435

Date: Sep 20,2012 Beijing Sincoheren Science & Technology Development Co.,Ltd Submitter: B-1105 Sinotrans Plaza 43# Xizhimen BeiDajie, Haidian District , Beijing, 100044, China Mr. Xin Wang Primary Contact Person: Quality Manager Beijing Sincoheren Science & Technology Development Co.,Ltd Tel: +86-(0)10-82294249-8002 Fax: +86-(0)10-82294249-8007 Mike Gu Secondary Contact Person: Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd Tel: +86-20-62321333 Fax: +86-20-86330253 IPL Therapy System Device: Trade Name: -Intense Pulsed Light Therapy System Common/Usual Name: Powered Light Based Non-Laser Surgical Instrument with Classification Names: Thermal Effect ONF Product Code: 21 CFR 878.4810 Regulation Number: Device Class: Class II Submission Purpose: New Device K093627 IPULSELIGHT IPL SYSTEM Predicate Device(s): Model SMQ-NYC; SMQ-NK The IPL Therapy Systems is an Intense Pulsed Light Therapy Device Description: System which delivers intense pulsed light at a wavelength ranging from 690nm -1200nm. Intense Pulsed Light (IPL) systems

work on the principles of selective photothermolysis. That is causing thermal damage to target chromophores by using light of appropriated wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL Therapy System is different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

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The Sincoheren IPL Therapy system controlled by computer is composed:

Main unit -
LCD monitor -
Treatment handle .

The embedded microprocessor monitors can control the system continually.

The operating Interface includes a full-LCD screen (8.0 inch), the key switch and emergency shut-off knob.

LCD screen both shows the system work program, treatment parameters and number of light emitting. The treatment handle operated by hand comprises the intense emitter and transmission system.

Differences between two models:

The differences between SMQ-NYC and SMQ-NK are:

The installation method was changed from stationary to . mobile;
The product shape:

	Differences	SMQ-NK	SMQ-NYC
1	Overall size(WDH)	840mm600mm500mm	490mm525mm952mm
2	Overall size of coolingcondenser	170mm160mm37mm	305mm160mm61mm

Please see the Appendix A for IEC 60601-1 test report.

the IPL Therapy Systems is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

IEC 60601-1Medical equipment medical electrical

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equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995

1. IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
  The intense pulsed light therapy system is indicated for use in Intended Use: surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690nm – 1200nm.

Technology: Proposed device and predicate device use a light based Non-Laser device that provides thermal effect including broad spectrum source devices such as Intense Pulse Light. Both devices emit Intense Pulsed Light (IPL) using Xenon Lamp.

The proposed device emits IPL at a wavelength ranging from 690nm-1200nm. The unit composes three parts: the main unit, control panel and treatment handle.

The Intense Pulsed Light Therapy System employs the same fundamental scientific technology as its predicate devices.

Determination of Summary of Non-Clinical Tests: Substantial Equivalence:

●

The Intense Pulsed Light Therapy System and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis ●
Requirements Reviews ●
Design Reviews . .
Raw materials verification ●
Testing on unit level (Module verification)
Integration testing (System verification)
Final acceptance testing (Validation)
Performance testing (Verification)

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Safety testing (Verification) .

Summary of Clinical Tests:

The subject of this premarket submission, Intense Pulsed Light Therapy System, did not require clinical studies to support substantial equivalence.

The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.

Beijing Sincoheren Science & Technology Development Co., Ltd Conclusion: considers the Intense Pulsed Light Therapy System to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 11, 2013

Beijing Sincoheren S&T Development Company, Limited % Guangzhou Osmunda Medical Device Consulting Company Mr. Mike Gu Regulatory Manager 7th Floor 982 Congyun Road, Baiyun District Guangzhou. Guangdong China 510420

Re: K123435

Trade/Device Name: Intense Pulsed Light Therapy 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: ONF Dated: December 20, 2012 Received: December 26, 2012

Dear Mr. Gu:

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

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Page 2 - Mr. Mike Gu

CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (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 Manufacturers, International 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.

For Sincerely yours,

Peter Dakumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K123435

Device Name: Intense Pulsed Light Therapy System

Indications for Use:

The intense pulsed light therapy system is indicated for use in surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690-1200nm.

CONDITIONS		SKIN TYPES
		I	II	III	IV	V	VI
HAIR	Wave
REMOVAL	length(nm)	690-1200	690-1200	690-1200	690-1200	690-1200	N/A
	Density	35-45J/cm²	30-40 J/cm²	25-30 J/cm²	20-35 J/cm²	20-25 J/cm²	-
	Program	Program3	Program2	Program2	Program1	Program1	-

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.02.08 15:30:58 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K123435

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.