(90 days)
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.
The Fiber laser Treatment systems (HS-232) is the desktop type, and (HS-233) is the mobile type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system)，fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is an Erbium(1550nm) and Thulium(1927nm) fiber laser, producing a pulsed beam upon activation by a footswitch. The system is equipped with a 650nm aiming beam with less than 2mW, the beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
The 1550nm laser and 1927nm laser works independently and cannot work together, the output laser source can be selected according to different indication for use
The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the Fiber Laser Treatment Systems (HS-232, HS-233). This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a dedicated study.
Therefore, the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a study proving the device meets acceptance criteria is not present in this document. The FDA 510(k) process for this type of device (laser surgical instrument) typically relies heavily on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing (electrical safety, EMC, performance against standards) and functional comparisons, rather than requiring extensive clinical trials with specific performance endpoints.
Here's a breakdown of what can and cannot be answered from the provided text:
What can be extracted:
- Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
- Intended Use/Indications for Use:
- 1550nm: Intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
- 1927nm: Intended for use in dermatological procedures requiring the coagulation of soft tissue.
- Non-Clinical Testing Performed: Electrical safety and electromagnetic compatibility based on several IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
- Clinical Testing: Not applicable, as stated in the document.
What cannot be extracted (as per your request, because the document doesn't contain a specific study demonstrating performance against acceptance criteria beyond general safety and equivalence):
- A table of acceptance criteria and the reported device performance: No specific performance acceptance criteria (e.g., minimum percentage of fractional skin resurfacing achieved, specific coagulation depth) or reported performance results (e.g., test scores, sensitivity, specificity, accuracy) are provided. The "performance testing" mentioned refers to verifying design specifications and compliance with standards, not performance against clinical or perceptual criteria.
- Sample size used for the test set and the data provenance: No clinical test set or data provenance is mentioned as clinical testing was not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test with expert-established ground truth was reported.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic device with human reader interaction.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical laser system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no ground truth was established for "performance" beyond compliance with engineering standards.
- The sample size for the training set: Not applicable as this is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided FDA document focuses on demonstrating that the Fiber Laser Treatment Systems are substantially equivalent to previously cleared predicate devices based on technological similarity, indications for use comparison, and compliance with general electrical safety and laser standards. It does not detail a study proving the device meets specific clinical performance acceptance criteria.
FDA 510(k) Clearance Letter - K251031
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
July 2, 2025
Shanghai Apolo Medical Technology Co., Ltd.
Felix Li
RA Supervisor
Building 11, Lane 1566, Nanle Road, Songjiang District
Shanghai, Shanghai 201613
China
Re: K251031
Trade/Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
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: ONG
Dated: March 26, 2025
Received: April 3, 2025
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
July 2, 2025
Shanghai Apolo Medical Technology Co., Ltd.
Felix Li
RA Supervisor
Building 11, Lane 1566, Nanle Road, Songjiang District
Shanghai, Shanghai 201613
China
Re: K251031
Trade/Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
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: ONG
Dated: March 26, 2025
Received: April 3, 2025
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 and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K251031 - Felix Li Page 2
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 systems (QS) regulation (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-
Page 3
K251031 - Felix Li Page 3
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: 2025.07.02 13:59:56 -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
Page 4
FORM FDA 3881 (6/20) 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: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K251031
Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
Indications for Use (Describe)
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.
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."
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
Indications for Use
See PRA Statement below.
510(k) Number (if known): K251031
Device Name: Fiber Laser Treatment Systems (HS-232, HS-233)
Indications for Use (Describe)
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.
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."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
510(k) #: K251031
Prepared on: 2025-05-30
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| 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)
| Field | Information |
|---|---|
| Device Trade Name | Fiber Laser Treatment Systems (HS-232,HS-233) |
| Common Name | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Classification Name | Powered Laser Surgical Instrument With MicrobeamFractional Output |
| Regulation Number | 878.4810 |
| Product Code(s) | ONG |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221770 | Fiber Laser Treatment System | ONG |
| K130193 | Fraxel® Dual 1550/1927 Laser System | GEX |
Device Description Summary
21 CFR 807.92(a)(4)
The Fiber laser Treatment systems (HS-232) is the desktop type, and (HS-233) is the mobile type. It consist of mainframe(touch-screen data input system, power supply control system and cooling system)，fiber treatment handpiece (laser output system ) and footswitch. The Fiber Laser Treatment System is an Erbium(1550nm) and Thulium(1927nm) fiber laser, producing a pulsed beam upon activation by a footswitch. The system is equipped with a 650nm aiming beam with less than 2mW, the beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
The 1550nm laser and 1927nm laser works independently and cannot work together, the output laser source can be selected according to different indication for use
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The 1550nm indication of the proposed device is same as the predicate,the 1927nm indication of the proposed device is covered by the
Page 6
predicate.
Technological Comparison
21 CFR 807.92(a)(6)
Discussion:
1550nm:
- Indication for use: the indication for use of the proposed device is the same as the predicated device.
- Technology: the proposed device utilizes the same technology as the predicates to achieve the intended use. The technical specifications including frequency, energy and pulse width are similar. Both devices meet the same standards of safety, EMC and performance requirements.
- Material: The handpiece tip that contacts the patient are identical to that of the Fiber Laser Treatment System (K221770) manufactured by Shanghai Apolo, including the material, color, size, etc., so the contact part of the handpieces of the both devices comply with ISO 10993-1.
1927nm:
Analysis 1: The indication for use of the proposed device is covered by the predicated devices.
Analysis 2: From the above comparison, the output power of proposed device is 15W, the output power of predicate device is not exactly same, but the output power of proposed device is similar with higher value of output power of the predicate device, the minor difference does not the affect the indication of proposed device. The pulse energy is largely same as the predicate device, only the lowest energy is different, the lower pulse energy does not arise new safety issues.
Analysis 3: The aiming beam and treatment area of the proposed device are similar with the predicate device's, the spot size and of the proposed device is within the range of the predicate device, so those minor difference does not affect the safety and effectiveness of device.
Analysis 4: The 1550nm and 1927nm laser using the same handpiece with treatment tip to output the laser power. The handpiece tip that contacts the patient are identical to that of the Fiber Laser Treatment System (K221770) manufactured by Shanghai Apolo, including the material, color, size, etc.
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
Clinical Testing:
It is not applicable.
Conclusions:
Based on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.
§ 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.