(243 days)
No
The provided text describes a standard Intense Pulsed Light (IPL) system based on the principles of selective photothermolysis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The device description focuses solely on the physical principles of IPL and its application for hair removal.
No.
The device is indicated for hair removal in "surgical, aesthetic and cosmetic applications," which are not typically considered therapeutic uses.
No
The device description clearly states its purpose is for "surgical, aesthetic and cosmetic applications in the hair removal," not for identifying or diagnosing diseases or conditions.
No
The device description explicitly states it is an "intense pulsed light system" and includes "handpieces used to deliver pulsed-light energy," indicating it is a hardware device that delivers energy.
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 applications in the hair removal". This is a therapeutic and cosmetic application performed directly on the patient's body.
- Device Description: The device description explains how the IPL system works by delivering light energy to target chromophores in the skin for hair removal. This is a physical interaction with the body, not an analysis of samples taken from the body.
- Lack of IVD Characteristics: 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 used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This IPL system does not fit that description.
N/A
Intended Use / Indications for Use
The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.
Product codes
ONF
Device Description
The IPL Therapy Systems (ST-AI) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 640nm-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 appropriate 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. Based on this, the IPL Therapy Systems (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GSD INTENSE PULSED LIGHT SYSTEM (K091664), Angelite Family of Intense Pulsed Light System (K083915)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Section 1 510(k) Summary
MAR - 8 2011
| Prepared Date: Jul. 02, 2010 | |
|---|---|
| As required by 807.97 | |
| The assigned 510(k) Number is | |
| Sponsor | Beijing Starlight Science & Technology Development Co., |
| Ltd. | |
| Fuwei Road No.2A Xihongmen Town | |
| Daxing District,Beijing,100076,P.R.China | |
| Mr. XinChang Tu | |
| Board Chairman | |
| Tel:+86-10-60252039 | |
| Fax: +86-10-60252073 | |
| Email: starlightipl@yahoo.com.cn | |
| Submission | Ms. Diana Hong / Mr. Tarzan Wang |
| Correspondent | Shanghai Mid-Link Business Consulting Co., Ltd |
| Sute 5D, No.19, Lane 999, Zhongshan No.2 Road(S) | |
| Shanghai, 200030, China | |
| Tel: +86-21-64264467 | |
| Fax: 240-238-7587 | |
| Email: diana.hong@mid-link.net | |
| Proposed Product | |
| Trade Name | |
| Model | |
| Product Code: | |
| Regulation Number: | |
| Device Class: | IPL Therapy Systems |
| ST-AI | |
| ONF | |
| 21 CFR 878.4810 | |
| Class II | |
| Submission Purpose: | New Device |
| Predicate Device: | GSD INTENSE PULSED LIGHT SYSTEM (K091664) |
| Angelite Family of Intense Pulsed Light System (K083915) | |
| Device Description | The IPL Therapy Systems (ST-AI) is an intense pulsed |
| light system which delivers intense pulsed light at a | |
| wavelength ranging from 640nm-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 appropriate wavelength in |
1
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. Based on this, the IPL Therapy Systems (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal. Test Conclusion The IPL Therapy Systems is designed, tested and will be manufactured in accordance with both mandatory and voluntary standards, including: IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995. IEC 60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2: 2001 with Amendment 1: 2004; Edition 2.1 (Edition 2: 2001 consolidated with Amendment 1:2004) SE Determination 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. Intended The IPL Therapy Systems (inclusive of the handpieces used Use/Indication for Use to deliver pulsed-light energy) is indicated for use in surgical. aesthetic and cosmetic applications in the hair removal at a wavelength ranging from 640nm-1200nm.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Beijing Starlight Science and Technology Development Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong Suite 5D. No. 19. Lane 999 Zhongshan No. 2 Road (S) Shanghai, 200030, China
MAR - 8 2011
Re: K101901
Trade/Device Name: IPL Therapy Systems 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: ONF Dated: February 25, 2011 Received: February 25, 2011
Dear Ms. Hong:
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.
3
Page 2 - Ms. Diana Hong
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 (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/ReportalProblem/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,
Alis B. R. h
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510(k) Number (if known):
Device Name: __ IPL Therapy Systems (ST-A)
Indications for Use:
The IPL Therapy Systems (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in the hair removal.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Niloe for mano CD
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number_ K101901
Page 1 of 1