(204 days)
Not Found
No
The document describes a laser system with specific wavelengths and applications, and the performance studies focus on electrical safety, laser safety, biological evaluation, and software validation. There is no mention of AI, ML, image processing, or data sets for training or testing algorithms.
Yes
The conformity to IEC 60601-2-22:2012, which specifies requirements for "surgical, cosmetic, therapeutic and diagnostic laser equipment," indicates that this device falls under the therapeutic category.
No
The device is a picosecond laser system intended for surgical and aesthetic applications for the removal of tattoos and treatment of benign pigmented lesions. It is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a host, treatment handpiece, light guide system, foot switch, power cords, and accessories, indicating it is a physical laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "surgical and aesthetic application in the medical dermatology and general and plastic surgery." This involves direct treatment of the patient's body (in vivo).
- Device Description: The device description details a laser system designed to deliver energy to the skin for procedures like tattoo removal and treatment of pigmented lesions. This is a physical intervention on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue) or performing tests in vitro (outside the body) to diagnose a condition.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This laser system performs a therapeutic and aesthetic function directly on the patient.
N/A
Intended Use / Indications for Use
The Picosecond 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 Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.
The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).
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)
Non clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical IEC 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 compatibility - Requirements and tests
- 60601-2-22:2012, Medical electrical equipment - IEC Part 2-22: Particular requirements for basic 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
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Software Information: Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Bench Testing: Bench testing was performed to make sure that the device delivers set energy parameters within specifications.
No clinical study is included in this submission.
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/0 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.
Beijing ADSS Development Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
August 23, 2022
Re: K220268
Trade/Device Name: Picosecond 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: July 12, 2022 Received: July 22, 2022
Dear Boyle Wang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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 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
Indications for Use
510(k) Number (if known) K220268
Device Name Picosecond Laser System
Indications for Use (Describe)
The Picosecond 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K220268
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
| Name: | Beijing ADSS Development Co., Ltd. |
|---|---|
| Applicant address: | F2,Building 1,Jinyuan Road 36 Daxing Economic Development |
| Zone, 102628 Beijing, PEOPLE'S REPUBLIC OF CHINA | |
| Production address: | Fuda Road - Tongsheng Road, Southern Area of Industrial |
| Park,Gu'an County, 065599 Langfang City, Hebei Province, | |
| PEOPLE'S REPUBLIC OF CHINA | |
| Tel: | 86-13051615111 |
| Contact: | Song Ying |
Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|---|---|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, |
| 200120 China | |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date of Preparation: Jul.12th,2022
2.0 Device Information
| Trade name: | Picosecond Laser System |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Classification name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Model(s): | PS10-A, PS10-B |
| Production code: | GEX |
| Regulation number: | 21CFR 878.4810 |
| Classification: | Class II |
| Panel: | General & Plastic Surgery |
3.0 Predicate Device
4
Manufacturer: Shanghai Apolo Medical Technology Co., Ltd. Trade/Device Name: PicoSecond Nd: YAG Laser System 510(k) number: K200116
4.0 Device Description
The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.
The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).
5.0 Indication for Use Statement
The Picosecond 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.
5
510(k) Summary
K220268
6.0 Comparison to the Predicate Device
| Item | Subject device | Predicate device 1(Primary)
K200116 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device
Name | Picosecond Laser System | PicoSecond Nd: YAG Laser
System |
| Manufacturer | Beijing ADSS Development
Co., Ltd. | Shanghai Apolo Medical
Technology Co., Ltd. |
| Class &Code | Class II
GEX 878.4810 | Class II
GEX 878.4810 |
| Intended
Use/Indication
for Use | The Picosecond 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 | 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 |
| | 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. | the following tattoo colors:
red, yellow and orange. - Treatment of benign pigmented
lesions on Fitzpatrick skin types
I-IV. |
| Type of Use | Prescription Use | Prescription Use |
| Wavelength | 1064/532 nm | 1064/532 nm |
| Pulse Duration
(Pulse Width) | 500ps | 300 – 500 ps |
| Pulse Energy | 500mJ(1064nm)
250mJ (532nm) | 500mJ(1064nm)
250mJ (532 nm) |
| Peak Power
(Gigawatts) | 1.0 | Not Publicly Available |
| Aiming Beam | 635nm | Not Publicly Available |
| Repetition
Rate | 110Hz | Single, 1, 2, 3, 4, 5,10mm |
6, 7, 8, 9, 10 Hz |
| Spot size | 2mm-10mm | Adjustable spot size
2
| Maximum
Average
Fluence
( J/cm²) | 1064 nm: 15.5 J/cm²
532 nm: 8 J/cm² | Not Publicly Available |
| Laser Type | Nd:YAG | Nd:YAG |
6
510(k) Summary
K220268
7
K220268
8
K220268
| Activation | foot-switch | foot-switch |
|---|---|---|
| Display | LCD Touch screen | LCD Touch screen |
| Cooling | ||
| System | Internal water to air heat | |
| exchanger | Cooling System | |
| Electrical | ||
| Power | AC 230V, 50Hz | 120VAC 10A, |
| 50/60Hz | ||
| Beam Delivery | ||
| System | Articulated Arm with | |
| Handpiece | Articulated Arm with Handpiece | |
| System | ||
| dimension | 93cm × 40 cm × 93 cm | 97cm H x 48cm W x 97cm D |
| System Weight | ||
| (kg) | 128 kg | 130kg |
9
Analysis:
From the comparison table, the subject device and predicate device have the same Intended use & Indications for Use, and comparable technological parameters,
7.0 Non-Clinical Tests
Non clinical tests were conducted to verify that the subject device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical IEC 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 compatibility - Requirements and tests
- 60601-2-22:2012, Medical electrical equipment - IEC Part 2-22: Particular requirements for basic 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
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Software Information: Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Bench Testing: Bench testing was performed to make sure that the device delivers set energy parameters within specifications.
8.0 Clinical Test Conclusion
No clinical study is included in this submission.
9.0 Conclusion
Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.