(131 days)
No reference devices were used in this submission.
No
The summary does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
No.
The intended use of the device is for hair removal and permanent hair reduction, which are cosmetic procedures, not therapeutic treatments for a disease or medical condition.
No
The device is described as a Diode Laser Therapy System intended for hair removal and permanent hair reduction, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it consists of a console, treatment hand piece, and foot switch, which are hardware components. It also describes the physical mechanism of action (diode laser emitting a wavelength).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction. This is a therapeutic/cosmetic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that emits light to target hair follicles. This is a physical intervention, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Axilla, Face, bikini, Upper limb and lower limb
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The laser output window of testing included the following tests: Cytotoxicity, Sensitization, Irritation.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60825-1 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure of latent design flaw could directly result in minor injury to the patient or operator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Beijing Sincoheren Science And Tech. Development Co., Ltd % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology Service Co., Ltd 7th Floor, Jingui Business Building, No.982 Congyun Rd. Baiyun District Guangzhou, 510420 CN
Re: K152898
Trade/Device Name: Diode Laser Therapy Systems 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 20, 2015 Received: October 1, 2015
Dear Mr. Gu:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152898
Device Name
Diode Laser Therapy Systems, Model SDL-B
Indications for Use (Describe)
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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:
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."
3
Image /page/3/Picture/0 description: The image is a close-up of a logo or symbol set against a green background. The logo features stylized white lines that form an abstract design. The lines appear to be interconnected, creating a sense of unity or network. The overall impression is modern and clean, with the white lines contrasting sharply against the solid green backdrop.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Beijing Sincoheren Science and Technology Development Co., Ltd. Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044, China Phone: +86-(0)10-57734966
Fax: +86-(0)10-82290038
| Primary Contact Person: | Mike Gu |
|---|---|
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Secondary Contact Person: | Xin Wang |
| Quality Manager | |
| Beijing Sincoheren Science and Technology Development | |
| Co., Ltd. | |
| Tel: (+86) 10-82294249-8002 | |
| Fax: (+86) 10-82294249-8007 |
II. DEVICE
| Name of Device: | Diode Laser Therapy Systems, Model SDL-B |
|---|---|
| ----------------- | ------------------------------------------ |
| Name of Device: | Diode Laser Therapy Systems, Model SDL-B |
|---|---|
| Common/Usual Name: | Diode Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |
PREDICATE DEVICE lll.
4
Image /page/4/Picture/0 description: The image is a green square with a white design on it. The design appears to be abstract, possibly representing a stylized plant or organic form. The white color contrasts sharply with the green background, making the design stand out. The overall impression is simple and modern.
Emvera Diolux, K123257
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Diode Laser Therapy Systems mainly consist of console, treatment hand piece and a foot switch. The diode laser emits wavelength of 808nm from the treatment hand piece, the wavelength effectively penetrates deep into and absorbed by the target chromophore. The adequate pulse duration, energy density and epidermal cooling ensure an adequate thermal damage to the target tissue without damaging the surrounding tissue to achieve effective hair removal.
V. INDICATION FOR USE
The Diode Laser Therapy Systems are intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI).
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.
| Specification | Predicate device | Proposed device | Discussion of
Differences |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| K number | K123257 | -- | |
| Manufacturer | Emvera Technologies, LLC. | Beijing Sincoheren Science and
Technology Development Co., Ltd. | |
| Device name | Emvera Diolux | Diode Laser Therapy Systems | |
| Intended Use | The Emvera Diolux is intended for
hair removal, permanent hair
reduction on all skin
types (Fitzpatrick skin type I-VI).
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 Therapy Systems
are intended for hair removal,
permanent hair reduction on all skin
types (Fitzpatrick skin type I-VI).
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 |
VI. SUBSTANTIAL EQUIVELENCE
5
Image /page/5/Picture/0 description: The image shows a green square with a white design on it. The design appears to be a stylized representation of a plant or a symbol. The white design is abstract and fills most of the square, with some parts extending to the edges.
| Specification | Predicate device | Proposed device | Discussion of Differences |
|---|---|---|---|
| Wavelength | |||
| (nm) | 808 | 808 | Same |
| Output power | |||
| (W) | 600 | 500 | Less than the |
| output of | |||
| predicate | |||
| device. | |||
| Fluence (Energy | |||
| Density) |