(114 days)
Not Found
No
The description focuses on the laser technology and its physical components, with no mention of AI, ML, or related concepts.
Yes
The device is described as "The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue," which indicates it is used for medical treatment.
No
The device is described as a "Fiber Laser Treatment System" used for "dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it consists of hardware components such as a mainframe, fiber treatment handpiece, and footswitch, in addition to a touch-screen data input system which could be considered software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a laser system that delivers light to the skin for treatment. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat tissue.
N/A
Intended Use / Indications for Use
The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
ONG
Device Description
The Fiber laser Treatment system (HS-230) is the desktop 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 a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
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)
A series of tests to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1:Equipment classification and requirements
IEC 60601-2-22:2007 Medical electrical equipment-Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 13, 2022
Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor Contact Address
Re: K221770
Trade/Device Name: Fiber Laser Treatment 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: ONG Dated: July 6, 2022 Received: July 13, 2022
Dear Felix Li:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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,
Jianting Wang Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K221770
Device Name Fiber Laser Treatment System
Indications for Use (Describe)
The Fiber Laser Treatment System is in dermatological procedures requiring fractional skin resurfacing and 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) |
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K221770 Section 3-510(k) summary
I Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China
Establishment Registration Number: 3007120647
Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn
II Proposed Device
| Trade Name of Device: | Fiber Laser Treatment System |
|---|---|
| Common name: | Laser Surgical Instrument For Use In General And Plastic |
| Surgery And In Dermatology | |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | ONG |
| Review Panel: | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K192350 |
|---|---|
| Trade name: | Medical Non-ablative Fractional Laser Systems |
| Common name: | Laser Surgical Instrument For Use In General And Plastic |
| Surgery And In Dermatology | |
| Classification: | Class II |
| Product Code: | ONG |
| Manufacturer | Wingderm Electro-Optics Ltd. |
IV Device description
The Fiber laser Treatment system (HS-230) is the desktop 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.
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The Fiber Laser Treatment System is a Erbium fiber laser, producing a pulsed beam of near-infrared light (1550nm) upon activation by a footswitch. The beam is then directed to treatment zone by mean of an optical fiber couple to a handpiece.
V Indication for use
The Fiber Laser Treatment System is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.
| VI Comparison of technological characteristics with the predicate devices | ||
|---|---|---|
| Item | Proposed device | Predicate device |
| (K130193) | ||
| Product name | Fiber Laser Treatment System | Medical Non-ablative Fractional |
| Laser Systems | ||
| Product Code | ONG | ONG |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Model | HS-230 | WFB-01 |
| Indication for use | The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. | The Medical Non-ablative Fractional Laser Systems (Model: WFB-01) is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. |
| Laser Type | Erbium glass | Erbium glass |
| Components | Laser system, Color touch screen, Fiber handpiece, Footswitch | Laser system, Color touch screen, Fiber, handpiece Footswitch. |
| Wavelength | 1550nm | 1550nm |
| Output power | 15W | 15W |
| Pulse energy | 1-70mJ | Up to 70mJ |
| Pulse width | 10ms | 10ms |
| Beam delivery system | Fiber and handpiece | Fiber and handpiece |
| Laser beam diameter | 110μm | 110μm |
| Beam diameter variability | Fixed | Fixed |
| Dot Density | 25~484 (18 level) | 500 |
| (Dot/cm²) | ||
| Laser | ||
| emission | ||
| control | Footswitch | Footswitch |
| Scanning area | Adjustable, | |
| Maximum treatment area : | ||
| 20mm*20mm | AccuTip: 10mm*10mm, | |
| EffiTip: 20mm*20mm | ||
| GrowTip: 10mm*20mm | ||
| Laser class | Class 4 | Class 4 |
| Operation | ||
| interface | Color LCD touch screen | Color LCD touch screen |
| Power supply | 100-240VAC, 50/60Hz | 100-240VAC, 50/60Hz, |
| Software | Yes | Yes |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 |
| Performance | Comply with IEC 60601-2-22 and IEC | |
| 60825-1 | Comply with IEC 60601-2-22 and | |
| IEC 60825-1 | ||
| Material | ||
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
VI Comparison of technological characteristics with the predicate devices
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VII Non-Clinical Testing
A series of tests to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:
Electrical safety and electromagnetic compatibility
IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1:2014 Safety of Laser products-Part 1:Equipment classification and requirements
IEC 60601-2-22:2007 Medical electrical equipment-Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
VIII Clinical Testing
lt is not applicable.
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IX Conclusion
The proposed device has the same/similar indication for use, has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is safety and effectiveness as the predicated device. Accordingly, the proposed device is substantially equivalent to the predicate device.