(96 days)
Not Found
No
The description focuses on the physical principles of IPL and the system's components, with no mention of AI or ML capabilities. The control system is described as a microprocessor monitoring and controlling the system, which is standard for medical devices and does not imply AI/ML.
Yes
The device is described as an "Intense Pulsed Light Therapy System" and its intended use is for "surgical, aesthetic and cosmetic application in the hair removal," which indicates it is used for therapeutic purposes.
No
Explanation: The "Intended Use / Indications for Use" section states the device is for "hair removal," which is a therapeutic or cosmetic application, not a diagnostic one. The "Device Description" also focuses on light delivery for treatment purposes.
No
The device description explicitly lists hardware components such as a main unit, LCD monitor, and treatment handle, indicating it is a physical device that utilizes software for control and monitoring, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical, aesthetic and cosmetic application in the hair removal". This describes a therapeutic or cosmetic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers intense pulsed light to the skin. This is a physical treatment method, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical, aesthetic and cosmetic application
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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) | 840mm600mm | ||
| 500mm | 490mm525mm95 | ||
| 2mm | |||
| 2 | Overall size of cooling | ||
| condenser | 170mm160mm | ||
| 37mm | 305mm160mm61 | ||
| mm |
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
2
equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995
-
- 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.
- 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.
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)
18
3
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