(88 days)
Not Found
No
The device description focuses on standard laser and cooling systems, power control, and a user interface. There is no mention of AI, ML, or any features that would suggest adaptive learning or complex data processing beyond basic control. The performance studies also focus on safety and electrical standards, not AI/ML performance metrics.
Yes.
The device's description and intended use clearly state it is for "hair removal" and "permanent hair reduction," which are cosmetic and therapeutic applications. Additionally, one of the compliance standards listed is "IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," which specifically includes therapeutic laser equipment.
No
The device is intended for hair removal and permanent hair reduction, which are cosmetic or therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a water cooling system, power system, handpiece system, and main circuit power supply system, in addition to the user interface and control systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "hair removal, permanent hair reduction". This is a therapeutic or cosmetic procedure performed directly on the patient's body.
- Device Description: The description details a laser system with components like a water cooling system, power system, user interface, handpiece, and control systems. These are all consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device operates directly on the body for a physical treatment.
N/A
Intended Use / Indications for Use
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Product codes
GEX
Device Description
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device has six main function modules as following:
Water cooling system:
Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system.
Power system:
Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system.
User Interface system:
Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system.
Handpiece system:
According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system.
Main circuit power supply system:
The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system.
Main circuit control system:
It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.
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 proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- AAMI/ANSI/ES 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - 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.
- 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
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
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.
December 10, 2019
Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., Fangshan District Beijing, 102401 China
Re: K192516
Trade/Device Name: Diode Laser 808nm, Model: SL-HR10 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: September 10, 2019 Received: September 13, 2019
Dear Ray 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
1
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 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,
Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT5: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Diode Laser 808nm, Model: SL-HR10
Indications for Use (Describe)
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
| 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:
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Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"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."
3
510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation
09/10/2019
- Date of Preparation
-
Sponsor 2.
Beijing Superlaser Technology Co., Ltd.
No.2 Zhongfu Street, Economic and Technological Industrial Zone, Xihongmen Town, Daxing District, Beijing, 100076, China
Contact Person: Shi Shuang Position: Registration Specialist Tel: 86-10-81284899 to 806 Fax:86-10-81284899 Email: 672257488@qq.com
3. Submission Correspondent
Ray Wang General Manager
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
4
4. Identification of Proposed Device
Trade Name: Diode Laser 808nm Common Name: Powered Laser Surgical Instrument Model(s): SL-HR10
Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Indication For Use:
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
5. Device Description
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device has six main function modules as following:
Water cooling system:
Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system.
Power system:
Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system.
User Interface system:
Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system.
Handpiece system:
According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system.
5
Main circuit power supply system:
The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system.
Main circuit control system:
It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.
6
6. Identification of Predicate Device
510(k) Number: K181019 Product Name: Diode laser System Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd.
510(k) Number: K180353 Product Name: Diode laser hair removal device Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
AAMI/ANSI/ES 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-22 Edition 3.1 2012-10, Medical Electrical Equipment - 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.
-
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
-
ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
-
ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
7
9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device
K180353 | Predicate Device
K181019 | Remark |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | GEX | SAME |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Intended Use | The Diode Laser 808nm is
intended for hair removal,
permanent hair reduction on
all skin types (Fitzpatrick
skin type I-VI), including
tanned skin.
Permanent hair reduction is
defined as the long-term,
stable reduction in the
number of hairs regrowing
when measured at 6, 9, and
12 months after the
completion of a treatment
regime. | The Diode laser hair removal
device is intended for hair
removal, permanent hair
reduction on all skin types
(Fitzpatrick skin type I-VI),
including tanned skin.
Permanent hair reduction is
defined as the long-term, stable
reduction in the number of
hairs regrowing when measured
at 6, 9, and 12 months after the
completion of a treatment
regime. | The Diode Laser System is
intended for hair removal,
permanent hair reduction
on all skin types
(Fitzpatrick skin type
I-VI), including tanned
skin.
Permanent hair reduction is
defined as the long-term,
stable reduction in the
number of hairs regrowing
when measured at 6, 9, and
12 months after the
completion of a treatment
regime. | SAME |
| Configuration | Main Unit | Main Unit | Main Unit | SAME |
| | Handpiece | Handpiece | Handpiece | SAME |
| | Foot Control | Foot Control | Foot Control | SAME |
| Principle of
Operation | Diode Laser | Diode Laser | Diode Laser | SAME |
Table 7-1 General Comparison
8
| Item | Proposed Device | Predicate Device
K180353 | Predicate Device
K181019 | Remark |
|-------------------------|----------------------------|-----------------------------|-----------------------------|------------|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SAME |
| Laser
Classification | Class IV | Class IV | Class IV | SAME |
| Laser Wavelength | 808 nm | 808 nm | 808 nm | SAME |
| Spot Size | $1.2 cm^2$ | $1.44 cm^2$ | $1.2 cm^2$ | SAME |
| Fluence | $1-70J/ cm^2$ | $1-100J/ cm^2$ | $5-40J/ cm^2$ | Discussion |
| Frequency | 1-20 Hz | 1-20 Hz | 1-5 Hz | SAME |
| Pulse Duration | 5400ms | 10400ms | 30-200ms | SAME |
| Power Supply | 110V 60 Hz or 230V
50Hz | AC 110V/60Hz | 100-240V 50/60Hz | SAME |
| Dimension
(LWH) | 598mm x 440mm x
1093mm | 560mm x 380mm x 180mm | 450mm x 550mm x380mm | SIMILAR |
| Weight | 60Kg | 60Kg | 50 Kg | SAME |
Table 7-2 Performance Comparison
Discussion
The proposed device is different in fluence from the predicate device, the difference is very slight, and only in the range, the max. fluence of proposed device is between the two predicate devices, which means the proposed device could accomplishment the same indication for use with two predicate device. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test , IEC60825-1 test and performance test(Energy density and Spot Size), the safety and performance of the product can be ensured.
So the proposed device is determined to be substantially equivalency with predicate device.
9
| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| K180353 | K181019 | |||
| Patient Contact Materials and Biocompatibility | ||||
| Patient Contact | ||||
| Materials | Sapphire in handpiece | Sapphire in handpiece | Sapphire in handpiece | SAME |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME |
| Sensitization | No evidence of sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
| Irritation | No evidence of irritation | No evidence of irritation | No evidence of irritation | SAME |
| EMC, Electrical and Laser Safety | ||||
| Electrical | ||||
| Safety | Comply with IEC 60601-1, IEC | |||
| 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | Comply with IEC 60601-1, IEC 60601-2-22 | SAME | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC 60601-2-22, IEC | |||
| 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, IEC 60825-1 | SAME |
Table 11-3 Safety Comparison
10. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.