(86 days)
No reference devices were used in this submission.
No
The device description focuses on laser technology and manual physician control of parameters, with no mention of AI or ML.
Yes
The device is indicated for use in tattoo removal, and the treatment of benign vascular and pigmented lesions, which are therapeutic applications.
No
Explanation: The device is described as a "Therapy System" and its intended use is for "tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue". These are all therapeutic actions, not diagnostic ones. The "Device Description" also explains its mechanism of action for breaking down pigment particles, which is a treatment process.
No
The device description explicitly lists hardware components such as a laser module, articulated arm, laser power supply, and cooling system, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser therapy system that uses light energy to treat various skin conditions and remove tattoos. It directly interacts with the patient's tissue (skin and subcutaneous tissue) and does not analyze samples taken from the body.
- Intended Use: The intended use is for therapeutic procedures (tattoo removal, treatment of lesions, incision, excision, ablation, vaporization of soft tissue), not for diagnostic testing of samples.
- Device Description: The description focuses on the laser technology, its components, and how it interacts with pigment particles within the body. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.
The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.
The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and subcutaneous tissue
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Q-Switched Nd: YAG Laser Therapy Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: Cytotoxicity, Sensitization, Irritation.
The handpiece is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Q-Switched Nd: YAG Laser Therapy Systems. The device complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.
Performance testing
Performance testing was conducted on the device according to IEC 60825-1.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
Animal Study
The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, does not require animal studies to support substantial equivalence.
Clinical Study
The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, 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.
No reference devices were used in this submission.
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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 2, 2017
Beijing Sincoheren Science And Technology Development Co. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,ltd. 8-9th Floor, R&d Building, No.26 Qinglan St, Panyu District Guangzhou, 510006 CN
Re: K163123
Trade/Device Name: Q-switched Nd:YAG Laser 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: GEX Dated: October 31, 2016 Received: November 8, 2016
Dear Mike 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. 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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163123
Device Name
O-Switched Nd: YAG Laser Therapy Systems
Indications for Use (Describe)
The Q-Switched Nd: Y AG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image is a green square with a white design on it. The design appears to be an abstract representation of a letter or symbol, possibly a stylized 'M' or a similar character. The white design contrasts sharply with the green background, making it stand out. The overall impression is that of a logo or emblem.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
SUBMITTER l.
Beijing Sincoheren Science and Technology Development Co., Ltd.
Address: Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044,
China
Phone: +86-(0)10-57734966
Fax: +86-(0)10-82290050
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6231 6262 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Huan Kong |
| Regulatory Affairs Engineer | |
| Beijing Sincoheren Science and Technology Development | |
| Co., Ltd. | |
| Tel: (+86) 10-62277431-8009 | |
| Fax: (+86) 10-82290050 | |
| Date prepared: | Oct 31, 2016 |
- II. DEVICE
| Name of Device: | Q-Switched Nd: YAG Laser Therapy Systems |
|---|---|
| Common/Usual Name: | YAG Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |
4
Image /page/4/Picture/1 description: The image is a close-up of a green square with a stylized white design. The design features curved lines that resemble a stylized letter or symbol, possibly a monogram or logo. The white lines are thick and bold, contrasting sharply with the green background. The overall impression is a simple yet distinctive graphic element.
PREDICATE DEVICE III.
Nd: YAG Laser System, K133158
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.
The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.
The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.
V. IDICATIONS FOR USE
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:
1064nm:
-Tattoo Removal
Dark ink: blue and black.
-Treatment of Benign Pigmented Lesions
Nevus of ota.
532nm:
-Tattoo Removal
Light ink: red.
Light ink: sky blue and green.
- Treatment of Benign Vascular Lesions
Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.
-Treatment of Benign Pigmented Lesions
Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.
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Image /page/5/Picture/1 description: The image is a green square with a white abstract design in the center. The design appears to be a stylized representation of a person or figure, with flowing lines suggesting movement or energy. The white figure contrasts sharply against the solid green background, making it the focal point of the image.
VI. TECHNOLOGY
The Q-Switched Nd: YAG Laser Therapy Systems works based on the principles of laser selective photothermy and blasting mechanism of Q-switched laser. Energy from particular wavelength with accurate dose act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanocytes from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enter into lymph circulation system and finally be discharged out of the body.
| Specification | Predicate device | Proposed device | Discussion of
Differences |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| K number | K133158 | -- | |
| Product Code | GEX | GEX | Identical |
| Manufacturer | Beijing Toplaser Technology
Co., Ltd | Beijing Sincoheren
Science and Technology
Development Co., Ltd. | |
| Device name | Nd: YAG Laser System | Q-Switched Nd: YAG
Laser Therapy Systems | Similar |
| Indications for use | 1064nm:
-Tattoo Removal
◇ Dark ink: blue and black
-Treatment of Benign Pigmented Lesions
◇ Nevus of ota
532nm:
-Tattoo Removal
◇ Light ink: red
◇ Light ink: sky blue and green
- Treatment of Benign Vascular Lesions
◇ Port wine birthmarks; Telangiectasias; Spider
angioma; Cherry angioma; Spider nevi
-Treatment of Benign Pigmented Lesions
◇ Cafe-au-lait birthmarks; Solar lentiginos; Senile
lentiginos; Becker's nevi; Freckles; Nevus spilus.
◇ | | Identical |
| Technology | Q-Switched ND:YAG and KTP
Nd: YAG Laser | Q -Switched ND:YAG and
KTP Nd: YAG Laser | Identical |
| Energy Source | Xenon Lamp | Xenon Lamp | Identical |
| Wavelength (nm) | 1064nm and 532nm | | Identical |
| Aiming beam
wavelength | 635nm | | Identical |
| Specification | Predicate device | Proposed device | Discussion of
Differences |
| Laser output mode | Q-switched pulse | Q-switched pulse | Identical |
| Aiming laser
output power |