(128 days)
Not Found
No
The summary describes a laser system with specific wavelengths and pulse characteristics for tattoo and lesion removal. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on compliance with electrical and laser safety standards.
Yes.
The device is used for removal of tattoos and treatment of benign pigmented lesions, which are aesthetic and medical treatments, therefore classifying it as a therapeutic device.
No.
The document describes the intended use of the device for surgical and aesthetic applications like tattoo removal and treatment of benign pigmented lesions, and does not mention diagnostic capabilities.
No
The device description explicitly lists multiple hardware components including a laser generator, articulated arm, handpiece, laser power supply, and cooling system, indicating it 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 about a person's health.
- Device Function: The PicoSecond Nd: YAG Laser System is a laser device that delivers energy to the skin for surgical and aesthetic applications (tattoo removal, treatment of pigmented lesions). It directly interacts with the patient's body.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from the patient. Its function is based on the direct application of laser energy to the skin.
Therefore, the intended use and description clearly indicate that this is a therapeutic and aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond 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. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.
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 was performed to verify 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, IEC 60601-1-2:2014, IEC 60601-2-22:2007+A1: 2012, IEC 60825-1:2014.
Clinical Testing: It is not applicable.
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.
0
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai Apolo Medical Technology Co., Ltd. % Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District Shanghai, 200071 Cn
Re: K200116
Trade/Device Name: PicoSecond Nd: YAG 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 16, 2020 Received: April 27, 2020
Dear Claire Zhang:
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.
1
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 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.
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Shanghai Apolo Medical Technology Co., Ltd. % Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District Shanghai, 200071 Cn
Re: K200116
Trade/Device Name: PicoSecond Nd: YAG 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 16, 2020 Received: April 27, 2020
Dear Claire Zhang:
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.
3
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 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.
Colin Kejing Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
4
K200116-510(k) summary
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China Preparation date: Apr. 09, 2020
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: | PicoSecond 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: | K191685 |
|---|---|
| Trade name: | PicoWay Laser System |
| Common name: | Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX |
| Manufacturer | Candela Corporation |
| 510(k) Number: | K173700 |
|---|---|
| Trade name: | Picoplus laser system |
| Common name: | Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX |
5
Lutronic Corporation Manufacturer
IV Device description
The PicoSecond Nd: YAG Laser System is a Nd: YAG solid state laser, which can deliver the energy at picosecond pulse bursts to the skin. The system is composed of laser generator, articulated arm, handpence, laser power supply, cooling system, display and control system.
The PicoSecond 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. The outputs of the two lasers are designed to be co-linear on the laser rail so that their beam paths are identical as they exit the laser system.
V Indication for use
Indication for use
The PicoSecond Nd: YAG Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:
1064nm wavelength:
- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
532nm wavelength:
- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
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 (K191685) | Predicate device (K173700) |
|---|---|---|---|
| Product name | PicoSecond Nd: | ||
| YAG Laser System | PicoWay Laser System | Picoplus laser system | |
| Product Code | GEX | GEX | GEX |
6
| Regulation
| No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
|---|---|---|---|
| Class | Class II | Class II | Class II |
| Indication | |||
| for use | The PicoSecond Nd: | ||
| YAG Laser System | |||
| is intended for use in | |||
| surgical and | |||
| aesthetic application | |||
| in the medical | |||
| dermatology and | |||
| general and plastic | |||
| surgery as follows: | |||
| 1064nm | |||
| wavelength: | |||
| • Removal of | |||
| tattoos on all | |||
| skin type | |||
| (Fitzpatrick skin | |||
| types I-VI) with | |||
| the following | |||
| tattoo colors: | |||
| black, brown, | |||
| green, blue and | |||
| purple. | |||
| • Treatment of | |||
| benign | |||
| pigmented | |||
| lesions on | |||
| Fitzpatrick skin | |||
| types I-IV. | |||
| 532nm wavelength: | |||
| • Removal of | The PicoWay laser | ||
| system is indicated | |||
| for the following at | |||
| the specified | |||
| wavelength | |||
| 532 nm: Removal of | |||
| tattoos for Fitzpatrick | |||
| skin types I - III to | |||
| treat the following | |||
| tattoo colors: red, | |||
| yellow and orange. | |||
| 730 nm: Removal of | |||
| tattoos for Fitzpatrick | |||
| skin types II - IV to | |||
| treat the following | |||
| tattoo colors: green | |||
| and blue. | |||
| 785 nm: Removal of | |||
| tattoos for Fitzpatrick | |||
| skin types II - IV to | |||
| treat the following | |||
| tattoo colors: green | |||
| and blue. | |||
| 1064 nm: Removal of | |||
| tattoos for all skin | |||
| types (Fitzpatrick I - | |||
| VI) to treat the | |||
| following tattoo | |||
| colors: black, brown, | |||
| green, blue and | |||
| purple. | |||
| The Picoway laser | |||
| system is also | |||
| indicated for benign | |||
| pigmented lesions | The Picoplus Laser | ||
| system is indication | |||
| for use in surgical | |||
| and aesthetic | |||
| application in the | |||
| medical specialties | |||
| of dermatology and | |||
| general and plastic | |||
| surgery as follows: | |||
| The 532 nm | |||
| wavelength and 450 | |||
| pico-second pulse | |||
| duration of the | |||
| PICOPLUS system | |||
| is indicated for | |||
| • Removal of | |||
| tattoos for | |||
| Fitzpatrick skin | |||
| types I-III with | |||
| the following | |||
| tattoo colors: | |||
| red, yellow and | |||
| orange. | |||
| • Treatment of | |||
| benign | |||
| pigmented | |||
| lesions removal | |||
| for Fitzpatrick | |||
| Skin Types I-IV. | |||
| The 1064 nm | |||
| wavelength and 450 | |||
| pico-second pulse | |||
| duration of the | |||
| PICOPLUS system | |||
| is indicated for: | |||
| Fitzpatrick skin | removal for | ||
| Fitzpatrick Skin | |||
| Types I - IV. | Removal of | ||
| tattoos on all | |||
| skin types | |||
| (Fitzpatrick skin | |||
| types I-VI) with | |||
| the following | |||
| tattoo colors: | |||
| types I-III with | |||
| the following | |||
| tattoo colors: | |||
| red, yellow and | |||
| orange. | The Resolve | ||
| handpiece (1064 nm) | |||
| is also indicated for | |||
| the treatment of acne | |||
| scars in Fitzpatrick | |||
| Skin Types II - V. | black, brown, | ||
| green, blue and | |||
| purple. | |||
| • Treatment of | |||
| benign | |||
| pigmented | |||
| lesions on | |||
| Fitzpatrick skin | |||
| types I-IV. | The Resolve | ||
| handpieces (532 nm | |||
| HE, 532nm, 1064nm) | |||
| are also indicated for | |||
| treatment of wrinkles | |||
| in Fitzpatrick Skin | |||
| Types I - IV | • Treatment of | ||
| benign | |||
| pigmented | |||
| lesions on | |||
| Fitzpatrick skin | |||
| types I-IV. | |||
| The Resolve Fusion | |||
| handpiece (1064 nm) | |||
| is indicated for the | |||
| treatment of wrinkles | |||
| as well as benign | |||
| pigmented lesions in | |||
| Fitzpatrick Skin | |||
| Types I - IV | The 1064 nm | ||
| wavelength and | |||
| nanosecond pulse | |||
| duration of the | |||
| PICOPLUS system | |||
| is indicated for: | |||
| The Resolve Fusion | |||
| handpiece (532 nm) | |||
| is indicated for the | |||
| treatment of benign | |||
| pigmented lesions in | |||
| Fitzpatrick Skin | |||
| Types I - IV. | • Treatment of | ||
| benign | |||
| pigmented | |||
| lesions on | |||
| Fitzpatrick skin | |||
| types I-VI | |||
| • Removal of dark | |||
| and mult | |||
| i-colored tattoos | |||
| containing dark | |||
| colored tattoo | |||
| inks on | |||
| Fitzpatrick skin | |||
| types I-VI | |||
| The 532 nm |
7
8
| | | | wavelength and
nanosecond pulse
duration of the
PICOPLUS system
is indicated for: | | | to be co - linear on
the laser rail so that
their beam paths are
identical as they exit
the laser system.
This allows the use
of a single delivery
system which can
output either the 532
nm or 1064
nm wavelengths. | linear on the laser rail
so that their beam
paths are identical as
they exit the laser
system. This allows
the use of a single
delivery system
which can output
either the 532 nm or
1064 nm
wavelengths. | | | | | | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---------------------------|---------------------------|----------------------------|-----------------------------|---------------------------------------------------|---------|
| | | | • Treatment of
benign
pigmented
lesions on
Fitzpatrick skin
types I-IV | Wavelengt
h (nm) | 1064nm | 532nm | 1064nm | 532nm | 1064nm | 532nm | | | 1064 nm);
Zoom handpiece
(532nm, 1064 nm). | |
| | | | • Removal of
lighter colored
tattoo inks,
including red
and yellow inks,
on Fitzpatrick
skin types I-III | Maximum
pulse
energy | 500mJ | 250mJ | 400mJ | 200mJ | 800mJ
(picosec
ond) | 300mJ
(picosec
ond) | System
dimension | 97cm H x 48cm W x
97cm D | 107 cm H x 46 cm W
x 69 cm D | unknown |
| Anatomical
site | Skin and
subcutaneous tissue | Skin and
subcutaneous tissue | | Pulse
duration | 300 – 500 ps | | 240-500ps | | 450ps | | System
weight | 130kg | 125kg | unknown |
| Technology | The PicoSecond Nd:
YAG Laser System
produces a pulsed
beam of coherent
near infrared
(1064nm) and
visible (532nm) light.
It can crush lesions
tissue efficient by
instantaneous emit
laser energy, 1064 &
532nm wavelength
act on the target
tissue in a short time
(300-500ps). The
outputs of the two
lasers are designed | The PicoWay Laser
System is a solid -
state laser capable of
delivering energy at
wavelengths of 1064
nm, 532 nm, 730 nm
or 785 nm at
extremely short
duration in the range
of 240 - 500 ps.
The 1064 nm
wavelength can be
frequency - doubled
to 532 nm as desired.
The outputs of the
two lasers are
designed to be co - | The PICOPLUS
Laser System is a
laser system,
delivering energy at
wavelengths of 1064
nm and 532 nm, both
at pulse durations of
450 picoseconds
(ps) and 2
nanoseconds (ns).
The laser system is
comprised of a
system console, an
articulated arm and
attached
handpieces. | Repetition
rate | Single, 1, 2, 3, 4, 5,
6, 7, 8, 9, 10 Hz | | Single, 1, 2, 3, 4, 5,
6, 7, 8, 9, 10 Hz | | N/A | | Electrical
requirements | 120VAC 10A,
50/60Hz | 200-240 VAC, 50/60
Hz, 30 A, 4600 VA
single | unknown |
| Spot size | Adjustable spot size
2~10mm | | 2, 3, 4, 5, 6, 7, 8, 9,
10 mm | | 1064nm
Handpiece 1
(450ps):
3, 5, 4 6mm
Handpiece 2: 6, 7, 8,
9, 10mm | 532nm
Handpiece 1
(450ps): 3.3, 4.3,
5.3mm
Handpiece 2: 4.3,
5.3, 6.5, 8mm | | | | | | | | |
| Beam
delivery | Articulated arm light
guide | | Articulated arm light
guide | | Articulated arm light
guide | | | | | | | | | |
| Handpiece | Zoom handpiece
(532nm, 1064 nm) | | Resolve handpieces
(532 nm HE, 532nm,
1064nm);
The Resolve Fusion
handpiece (532nm | | Handpiece 1, 2
(450ps) (1064nm,
532nm)
Handpiece1, 2 (2ns)
(1064nm, 532nm) | | | | | | | | | |
9
10
The indication of the proposed device is covered by the predicate. The maximum pulse energy of the proposed device is higher than the K191683, and lower than the K113700 predicate device. It can be considered that the propose device can achieve its intended use and is safety. The handpiece types of proposed device are less than the predicate devices. This difference does not affect the safety and effective of proposed device.
VII Non-Clinical Testing
A battery of tests was performed to verify 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 60601-2-22:2007+A1: 2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements
VIII Clinical Testing
It is not applicable.
IX Conclusion
The proposed device, PicoSecond Nd: YAG Laser System has the same the
11
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 determined that the subject device is substantially equivalent to the predicate device.