(160 days)
Not Found
No
The summary 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 data-driven algorithms for treatment planning, analysis, or execution. The device description focuses solely on the physical mechanism of action and wavelength ranges.
Yes
The device is indicated for the treatment of various medical conditions such as acne, benign pigmented lesions, and vascular lesions, which falls under therapeutic use.
No
The GSD Intense Pulsed Light System is indicated for treatment applications (e.g., acne, pigmented lesions, hair removal, vascular lesions), not for diagnosing conditions.
No
The device description explicitly states it is an "intense pulsed light system" which delivers light energy, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The provided information clearly states that the GSD Intense Pulsed Light System is used for surgical, aesthetic, and cosmetic applications directly on the human body (treatment of acne, pigmented lesions, hair removal, vascular lesions). It works by delivering light energy to target chromophores within the skin.
- Lack of Specimen Examination: There is no mention of examining specimens derived from the human body. The device interacts directly with the patient's skin.
Therefore, based on the provided information, the GSD Intense Pulsed Light System is a therapeutic device that uses light energy for various skin treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:
-
- Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
-
- Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
-
- Intense Pulsed Light from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.
Product codes
GEX, ONF
Device Description
The GSD Intense Pulsed Light System (GP666C4 and GP666C) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-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.
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)
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 3 510(k) Summary
NOV 1 & 2009
As required by 807.97
The assigned 510(k) Number is
091664
Page ① of ②
| Sponsor | Shenzhen GSD Tech. Co., Ltd
703,Building A, Futian TianAn Hi-tech,
Venture Park, Shenzhen, Guang Dong, China, 518040 |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ms. Qiu Xiaoming
Tel:+86-755-83433154
Fax: +86-755-83432881
Email: jwygsd@126.com |
| Submission
Correspondent | Ms. Diana Hong / Mr. Tarzan Wang
Shanghai Mid-Link Business Consulting Co., Ltd
Sute 8D, 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: | GSD Intense Pulsed Light System
GP666C4 & GP666C
GEX
21 CFR 878.4810
Class II |
| Submission Purpose: | New Device |
| Predicate Device: | Angelite Family of Intense Pulsed Light System (K083915)
SkinStation System(K030897)
Radiancy Mistral Device(K072331) |
| Device Description | The GSD Intense Pulsed Light System (GP666C4 and
GP666C) is an intense pulsed light system which delivers
intense pulsed light at a wavelength ranging from
400nm-1200nm. Intense Pulsed Light (IPL) systems work on
the principles of selective photothermolysis. That is, causing |
: {}
1
091664 page (2) of (2)
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.
The GSD Intense Pulsed Light system 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
Test Conclusion
Intended Use/Indication for Use
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.
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:
-
- Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
Intense Pulsed Light energy wavelengths from 2. 400nm-1200nm are indicated for the treatment of acne.
- Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
-
energy wavelengths .
Chi Intense Pulsed Light from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.
3-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text border and an emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem. The emblem itself features a stylized representation of a human figure with outstretched arms, symbolizing care and protection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 16 2009
Shenzhen GSD Tech Co., Ltd. % Shanghai Mid-Link Business Consulting Co., Ltd. Ms. Diana Hong, General Manager Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road(S) Shanghai, 200030, China
Re: K091664
Trade/Device Name: GSD Intense Pulsed Light System 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: November 5 2009 Received: November 9, 2009
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.
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.
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
3
Page 2 - Ms. Diana Hong
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/CDRH0ffices/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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkern
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): Pending
Device Name: __GSD Intense Pulsed Light System
Indications for Use:
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver ) pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lessons, hair removal, treatment of vascular lesions as following:
-
- Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
-
- Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
- Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions
Prescription Use J (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)
Niel RP del for nxn
(Division Sign off)
Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number K091664