(68 days)
K11:3588
Not Found
No
The summary describes a laser system for dermatological procedures and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The device is used for medical treatments such as tattoo removal, treatment of benign vascular and pigmented lesions, and skin resurfacing procedures, which are therapeutic applications.
No
The device is described as a Q-Switched Nd:YAG Laser System intended for various treatment procedures such as tattoo removal, treatment of vascular/pigmented lesions, skin resurfacing, incision, ablation, and vaporization of soft tissue. Its function is to produce and direct laser light for therapeutic purposes, not to diagnose medical conditions.
No
The device description explicitly states it is a "Q-Switched Nd: YAG Laser System" composed of hardware components like a laser generator, articulated arm, power supply, cooling system, display, control system, foot switch, and handpieces. This is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Q-Switched Nd: YAG Laser System is a therapeutic device that uses laser energy to directly treat conditions on the skin and subcutaneous tissue. It physically interacts with the patient's body to achieve its intended effects (tattoo removal, lesion treatment, etc.).
- Lack of Sample Analysis: The description does not mention any analysis of biological samples taken from the patient. The laser is applied directly to the affected area.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:
532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
1064nm wavelength:
- Removal dark ink (black, blue and brown) tattoo
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator, articulated arm, laser power supply, cooling system, display and control system, foot switch and others accessories.
The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.
The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.
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)
Non-Clinical Testing: A battery of tests were performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
- IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2007 Safety of Laser products-Part 1:Equipment classification and requirements
Clinical Testing: Not applicable.
Key Result: The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the word "ADMINISTRATION" in a smaller font size below "U.S. FOOD & DRUG".
Shanghai Apolo Medical Technology Co., Ltd. % Felix Li Regulatory Affairs 4F, Building A, No. 388 Yindu Road Xuhui District Shanghai, 200231 China
June 17, 2019
Re: K190936
Trade/Device Name: Q-Switched Nd: Y AG Laser 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: GEX Dated: April 4, 2019 Received: April 10, 2019
Dear Felix Li:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Acting Assistant Director, THT4A3: Light Based Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190936
Device Name
Q-Switched Nd: YAG Laser Systems
Indications for Use (Describe)
The Q-Switched Nd: Y AG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, incision, ablation, vaporization of soft tissue for general dermatology as follows:
532nm wavelength (nominal delivered energy of 585nm and 650mm with optional dye handpiece):
- Removal of light ink (red, sky blue, green, purple, and orange) tattoo
- Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- Treatment of benign epidermal pigmented lesions including, but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
1064nm wavelength:
- Removal dark ink (black, blue and brown) tattoo
- Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma.
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
| 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)
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510(k) Summary
I Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China
Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
II Proposed Device
| Trade Name of Device: | Q-Switched Nd: YAG Laser System |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | GEX |
| Review Panel: | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K113588 |
|---|---|
| Trade name: | SPECTRA Q-Switched Nd:YAG Laser |
| System with Dye Handpieces | |
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX |
| Manufacturer | Lutronic Corporation |
IV Device description
The Q-Switched Nd: YAG Laser System is based on the Q-Switch Nd: YAG and frequency-double Nd:YAG laser technology. The system is composed of laser generator,
4
articulated arm, laser power supply, cooling system, display and control system,foot switch and others accessories.
The Q-Switched Nd: YAG Laser System produces a pulsed beam of coherent near infrared (1064nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that concert the 532nm wavelength to 585nm and 650nm.
The Q-Switched Nd: YAG Laser System includes two models: HS-290K and HS-290EK.
V Indication for use
The Q-Switched Nd: YAG Laser System is intended for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, ablation, vaporization of soft tissue for general dermatology as follows:
532nm wavelength (nominal delivered energy of 585nm and 650nm with optional dye handpiece):
- · Removal of light ink (red. sky blue, green, purple, and orange) tattoo,
- · Treatment of benign vascular lesions including, but not limited to: telangiectasias,
- · Treatment of benign epidermal pigmented lesions including. but not limited to: cafe-au-lait, solar lentiginos, senile lentiginos, Becher's, nevi Freckles, Nevus spilus, Seborrheic Keratoses,
- · Treatment of Post Inflammatory Hyper-Pigmentation.
1064nm wavelength:
- · Removal dark ink (black, blue and brown) tattoo,
- · Removal of benign dermal pigmented lesions including, but not limited to: Nevus of OTA, Common Nevi, and Melasma,
- · Removal or lightening of unwanted hair with or without adjuvant preparation,
- · Skin resurfacing procedures for the treatment of acne scars and wrinkles.
VI Comparison of technological characteristics with the predicate devices
A table comparing the key features of the proposed and predicate devices is provided below.
| Item | Subject device | Predicate device
(K113588) |
|--------------|---------------------------------|-----------------------------------------------------------------|
| Product name | Q-Switched Nd: YAG Laser System | SPECTRA Q-Switched
Nd:YAG Laser System with
Dye Handpiece |
| Product Code | GEX | GEX |
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| Regulation
| No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
|---|---|---|
| Class | Class II | Class II |
| Indication for | ||
| use | The Q-Switched Nd: YAG Laser | |
| System is intended 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: | The SPECTRA Laser System is | |
| indicated for the Incision, | ||
| excision, ablation, vaporization | ||
| of soft tissues for general | ||
| dermatology, dermatologic and | ||
| general surgical procedure for | ||
| coagulation and hemostasis. | ||
| 532nm wavelength (nominal | ||
| delivered energy of 585nm and | 532nm Wavelength (normal | |
| 650nm with optional dye | delivered energy of 585nm and | |
| handpiece): | 650nm with optional dye | |
| handpieces): | ||
| Removal of light ink (red, sky | ||
| blue, green, purple, and orange) | ||
| tattoo Treatment of benign vascular | ||
| lesions including, but not limited | ||
| to: telangiectasias, Treatment of benign epidermal | ||
| pigmented lesions including, but | ||
| not limited to: cafe-au-lait, solar | ||
| lentiginos, senile lentiginos, | ||
| Becher's, nevi Freckles, Nevus | ||
| spilus, Seborrheic Keratoses Treatment of Post Inflammatory | ||
| Hyper-Pigmentation | Tattoo removal: light ink | |
| (red, tan, purple, orange, | ||
| sky blue, green) Removal of Epidermal | ||
| Pigment Lesions Removal of Minor | ||
| Vascular Lesions including | ||
| but not limited to | ||
| telangiectasias Treatment of Lentigines Treatment of Café-Au-lait Treatment of Post | ||
| Inflammatory | ||
| Hyper-Pigmentation Treatment of Becker's | ||
| Nevi, Freckles and Nevi | ||
| Spilus | ||
| 1064nm wavelength: | 1064nm Wavelength | |
| Removal dark ink (black, blue | ||
| and brown) tattoo Removal of benign dermal | ||
| pigmented lesions including, but | ||
| not limited to: Nevus of OTA, | ||
| Common Nevi, and Melasma. | Tattoo removal: dark ink | |
| (black, blue and brown) Removal of Epidermal | ||
| Pigment Lesions Removal of Nevus of Ota | ||
| Removal or lightening of unwanted hair with or without adjuvant preparation Skin resurfacing procedures for the treatment of acne scars and wrinkles | Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi Skin resurfacing procedure for the treatment of acne scars and wrinkle Treatment of melasma. | |
| Anatomical site | Skin and subcutaneous tissue | Skin and subcutaneous tissue |
| Technology | Q-Switched Nd: YAG amd KTP Nd:YAG Laser | Q-Switched Nd: YAG amd KTP Nd:YAG Laser |
| Pump lamp source | Xenon lamp | Xenon lamp |
| Wavelength (nm) | 1064nm/532nm | 1064nm/532nm |
| Aiming beam wavelength | 650nm | 655nm |
| Laser output mode | Q-Switched pulse | Q-Switched pulse |
| Maximum pulse energy | 1064nm wavelength: 1200mJ; | |
| 532nm wavelength:500mJ | ||
| SPT mode: 1400mJ | 1064nm wavelength: 1200mJ; | |
| 532nm wavelength:400mJ | ||
| SPT mode: 1500mJ | ||
| Pulse duration | ||
| Repetition rate | 4~6ns (Q-Switched mode) /300μs (SPT mode) | |
| Max,10Hz | 5~10nsQ-Switched mode )/300µs (Spectra mode) | |
| Max,10Hz | ||
| Nominal ocular hazard distance | 2580m | unknown |
| Spot size | Adjustable spot size 1~10mm | 3, 4, 5, 6, 7, 8mm/1, 2, 3, 4, 5, 6, 7mm (option) |
| Beam delivery | Articulated arm light guide | Articulated arm light guide |
| Cooling system | Water cooling, forced-air cooling, Copper Radiator | Closed internal circulating water cooling, outer circulation |
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| strong wind cooling | ||
|---|---|---|
| System | ||
| dimension | HS-290K: | |
| 11.8"(W)×32.7"(L)×34.6"(H) | ||
| HS-290EK: | ||
| 11.8"(W)×29.5"(L)×34.6"(H) | 11.6"(W)×25.8"(L)×66.93"(H) | |
| System | ||
| weight | HS-290K: 176.4lbs | |
| HS-290EK: 167.6 lbs | 194lbs | |
| Electrical | ||
| requirements | AC 110V, 50/60Hz | AC 220-230V, 50/60Hz |
| Maximum | ||
| power | 200MW | 240MW |
VII Non-Clinical Testing
A battery of tests were performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-22:2013 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2007 Safety of Laser products-Part 1:Equipment classification and requirements
VIII Clinical Testing
It is not applicable.
IX Conclusion
The proposed device, Q-Switched Nd: YAG Laser System has the intended use as the predicate device. It presents similar technological characteristics as the predicate device including the laser type, wavelengths, device design, pulse width, frequency, spot sizes. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.