Picosecond Nd:YAG Laser Systems (Model: HS-298)
Device Facts
| Record ID | K260017 |
|---|---|
| Device Name | Picosecond Nd:YAG Laser Systems (Model: HS-298) |
| Applicant | Shanghai Apolo Medical Technology Co., Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 9, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Picosecond Nd:YAG solid-state laser system; delivers picosecond pulse bursts of coherent 1064nm and 532nm light. System components include laser generator, articulated arm, handpiece (Zoom, MLA, or DOE), power supply, cooling system, and display/control interface. Laser outputs are co-linear on a rail, allowing single delivery system usage. Operated by clinicians in dermatology or plastic surgery settings. Device targets skin tissue for tattoo removal and benign pigmented lesion treatment. Output parameters (energy, pulse width, spot size, repetition rate) are controlled via the interface to achieve therapeutic effects. Benefits include precise energy delivery for aesthetic and surgical applications.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and performance verification of energy output, pulse width, wavelength, spot size, and repetition rate.
Technological Characteristics
Nd:YAG solid-state laser; 1064nm/532nm wavelengths. Pulse duration 300-500ps. Repetition rate 1-10Hz. Spot sizes 2-10mm. Delivery via articulated arm with Zoom, MLA, or DOE handpieces. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. Standalone system with integrated display and control.
Indications for Use
Indicated for tattoo removal and treatment of benign pigmented lesions. 1064nm: Tattoos (all skin types I-VI; black, brown, green, blue, purple); benign pigmented lesions (skin types I-IV). 532nm: Tattoos (skin types I-III; red, yellow, orange); benign pigmented lesions (skin types I-IV).
Regulatory Classification
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.
Predicate Devices
- PicoSecond Nd: YAG Laser System (K200116)
- Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (K241144)
- PICOANDY (Q-Switched Nd:YAG Laser) (K234104)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 9, 2026
Shanghai Apolo Medical Technology Co., Ltd.
Felix Li
RA Supervisor
Bldg. 11, Lane 1566, Nanle Rd., Songjiang District
Shanghai, 201613
China
Re: K260017
Trade/Device Name: Picosecond Nd:YAG Laser Systems (HS-298)
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: January 4, 2026
Received: January 5, 2026
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260017 - Felix Li
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K260017 - Felix Li
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assistance/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,
TANISHA
L. HITHE -S
Digitally signed by
TANISHA L. HITHE -S
Date: 2026.04.09
15:01:04 -04'00'
Tanisha Hithe
Assistant Director
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K260017 | |
| Device Name Picosecond Nd:YAG Laser Systems (HS-298) | |
| Indications for Use (Describe) | |
| 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. | |
| 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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| 510(k) #: K260017 | 510(k) Summary | Prepared on: 2026-04-07 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Shanghai Apolo Medical Technology Co., Ltd. | |
| Applicant Address | Building 11, Lane 1566, Nanle Road, Songjiang District Shanghai
Shanghai 201613 China | |
| Applicant Contact Telephone | +86-2134622015 | |
| Applicant Contact | Mr. Felix Li | |
| Applicant Contact Email | liqiang@apolo.com.cn | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Picosecond Nd:YAG Laser Systems (HS-298) | |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | |
| Classification Name | Powered Laser Surgical Instrument | |
| Regulation Number | 878.4810 | |
| Product Code(s) | GEX | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K200116 | PicoSecond Nd: YAG Laser System | GEX |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | GEX |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | GEX |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Picosecond Nd: YAG Laser System (HS-298) 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, handpiece, 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 Zoom handpiece, MLA handpiece, or DOE 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. This allows the use of a single delivery system which can output either the 532 nm or 1064nm wavelengths. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| 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. | | |
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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.
## Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the proposed device are the same as the predicate devices.
## Technological Comparison
21 CFR 807.92(a)(6)
The wavelengths (532nm, 1064nm) of the subject device are the same as the predicate devices K200116, K241144 and K234104.
The maximum output energy of Zoom handpiece (532nm,1064nm) is 250mJ and 500mJ respectively and is the same as predicate device K200116. The maximum output energy of MLA handpiece (532nm,1064nm) is 200mJ and 500mJ respectively, which is covered by the predicate devices K241144 (250mJ and 500mJ) and K234104(200mJ and 550mJ). The maximum output energy of DOE handpiece (532,1064nm) is 200mJ and 450mJ respectively, which is the same as the predicate K241144 (200mJ and 450mJ) and covered by the predicate device K234104 (200mJ and 550mJ).
The pulse duration of the Zoom handpiece (532nm,1064nm) is 300-500ps, which is the same as the predicate K200116. The pulse duration of the MLA/DOE handpiece (532nm,1064nm) is 300-500ps, which is similar to the predicate device K234104 (350ps-550ps), the minor difference does not affect the safety and effectiveness of the device.
The repetition rate of Zoom handpiece (532nm, 1064nm) is 1-10Hz, which is the same as the predicate device K200116. The repetition rate of MLA/DOE handpiece (532nm, 1064nm) is 1-10Hz, which is the same as the predicate devices K241144 and K234104.
The spot size of Zoom handpiece (532nm, 1064nm) is 2-10mm, which is the same as the predicate device K200116. The spot size of MLA handpiece (532nm, 1064nm) is 10mm, which is covered by the predicate devices K241144 (2-10mm) and K234104 (2-10mm). The spot size of DOE handpiece (532nm, 1064nm) is 6mm, which is covered by the predicate devices K241144 (2-10mm) and K234104 (2-10mm).
## Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
### 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+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance
- Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-22:2019 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
Performance testing on energy output, pulse width, wavelength, spot size and repetition rate.
### Clinical Testing:
It is not applicable.
### Conclusions:
Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate devices.
