(159 days)
Not Found
No
The summary describes a standard diode laser system for hair removal and general surgical procedures. There is no mention of AI, ML, image processing, or any data-driven algorithms. The performance studies focus on compliance with electrical and safety standards, not on the performance of an AI/ML model.
Yes
The device is intended for "dermatologic and general surgical procedures" and the performance studies include compliance with "Particular requirements for the safety of diagnostic and therapeutic laser equipment," indicating its therapeutic purpose.
No
The device is described as a surgical device intended for use in dermatologic and general surgical procedures, specifically for hair removal. Its function involves emitting a laser to cause a photothermal effect for hair removal. The "Summary of Performance Studies" section also refers to "therapeutic" laser equipment, further indicating its therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple hardware components including a semiconductor diode laser source, handpiece, footswitch, power supply system, central control system, cooling system, and safety features.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures" and "hair removal, permanent hair reduction." These are procedures performed directly on the patient's body, not on samples taken from the body (which is the hallmark of in vitro diagnostics).
- Device Description: The description details a laser system that delivers energy to the skin for therapeutic purposes (hair removal). It does not describe any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on safety standards for medical electrical equipment and biological evaluation of materials in contact with the body, not on the accuracy or performance of diagnostic tests on biological samples.
In vitro diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device operates externally on the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Diode Laser is intended for use in dermatologic and general surgical procedures.
The Standard Mode is intended for hair removal, permanent hair reduction.
The FHR Mode is intended for hair removal, permanent hair reduction.
The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal.
During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort.
The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.
The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and crystal which is made of sapphire.
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)
Bench 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:
1EC 60601-1-1:1988+A1:1991+A2:1995, Medical Electrical Equipment- Part 1: General requirements for safety.
IEC 60601-2-22: 1995, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
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
APR 2 1 2013
Exhibit #4 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K123483
-
Date of Submission: Nov 10, 2012
-
Sponsor
・
Beijing Syntech Laser Co., Ltd 5F, No.1 Building, No.65 Jiancaicheng West Road, Xisanqi, Haidian District, Beijing, 100096, P.R. China Establishment Registration Number: 3007535734 Contact Person: Jianghua Jin Position: Vice General Manager Tel: +86-10-82939866 Fax: +86-10-82935528 Email: Jeff@syntechlaser.com
- Submission Correspondent
Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
Proposed Device Identification 4.
Proposed Device Trade Name: Diode Laser Proposed Device Model: DLH-06 Proposed Device Common Name: Laser System Proposed Device Classification name: Powered Laser Surgical Instrument Classification: II
1
દ્વારા :
Product Code: GEX
Regulation Number: 21 CFR 878.4810
Review Panel: General& Plastic Surgery
0
Intended Use Statement:
The Diode Laser is intended for use in dermatologic and general surgical procedures.
The Standard Mode is intended for hair removal, permanent hair reduction.
The FHR Mode is intended for hair removal, permanent hair reduction.
The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
- Predicate Device Identification
510(k) Number: K112031
Product Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms.
Manufacturer: Alma Lasers, Inc.
6. Device Description
The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch.
The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal.
During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort.
The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature.
The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and
4-2
2
crystal which is made of sapphire.
| Item | Specification |
|---|---|
| Light type | Diode laser |
| Wavelength (nm) | 808 |
| Fluence (J/cm²) max | ≤10 (FHR) |
| ≤120 (Standard) | |
| Beam divergence (mard) | 10 (short side),40 (long side) |
| Spot Size (mm) | 12 X 10 |
| Pulse width (ms) | ≤20 ms(FHR) |
| 5-200 ms (Standard) | |
| Repetition rate (Hz) | ≤10 Hz(FHR) |
| ≤3 Hz(Standard) | |
| Skin cooling | Contact cooling |
| Dimensions (D X W X H,mm) | 460 X 365 X 350 |
| Weight (kg) | 26 kg |
| The energy measurement comparison | |
| between | |
| plan to use and leave the factory | -0.03% per working time |
| Cumulative measurement uncertainty | U=2%(k=2) |
Tab. III-1 device specification
Non-Clinical Test Conclusion 7.
Bench 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:
1EC 60601-1-1:1988+A1:1991+A2:1995, Medical Electrical Equipment- Part 1: General requirements for safety.
IEC 60601-2-22: 1995, Medical Electrical Equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.
IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility - Requirements and tests.
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
3
| ITEM | Proposed Device | Predicate Device
K112031 | | |
|-----------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| Light type | Diode laser | Diode laser | | |
| Wavelength
(nm) | 808 nm | 810 nm | | |
| Spot size | 1.2 cm² | same | | |
| Diode Module
Mode | FHR Mode | Standard Mode | SHR Mode
(Super Hair Removal ) | HR Mode |
| Indications for
Use | Intended for hair
removal, permanent
hair reduction | Intended for hair
removal, permanent
hair reduction | Intended for hair
removal, permanent
hair reduction | Intended for hair
removal, permanent hair
reduction |
| Fluency
(energy density) | ≤ 10 J/cm² | ≤ 120 J/cm² | same | same |
| Repetition Rate | ≤10 Hz | ≤3 Hz | same | same |
| Pulse Duration | ≤ 20 ms | 5-200 ms | same | Same |
| Dimension | 460 mmx365 mmx350mm (D x W x H) | 20" x22.4"x47" (494mm x569mm x 120mm) | | |
| Weight | 26 kg | 110 lbs.(49 kg) | | |
Technological Characteristics Comparison 8.
Tab. III-2 Technology Characteristics Comparison
9. Substantially Equivalent Conclusion
The wavelength of proposed device is similar as that of the slight difference of 2 nm will not raise new problems in safety and Effectiveness; The treatment modes and their corresponding IFU of the proposed device are covered by those of predicate device; this item is considered to be substantially equivalency; there is difference on the dimension and weight between proposed device and predicate device, the physical specification will not raise new problem in safety and effectiveness
The proposed device, Diode Laser, is determined to be Substantially Equivalent (SE) to the predicate device, Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platform (K112031) in respect of safety and effectiveness.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
April 21, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Beijng Syntech Laser Co., Ltd. % Mid-Link Consulting Co., Ltd. Ms. Diana Hong, General Manager P.O. Box 237-023 Shanghai, 200237, China
Re: K123483
Trade/Device Name: Diode Laser 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: February 21, 2013 Received: April 01, 2013
Dear Ms. Hong:
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
5
Page 2 - Ms. Diana Hong, General Manager
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, FOR
Peter D. Ruimm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Exhibit #5 Indications for Use
510(k) Number: Device Name:
Indications for Use:
The Diode Laser is intended for use in dermatologic and general surgical procedures.
The Standard Mode is intended for hair removal, permanent hair reduction.
The FHR Mode is intended for hair removal, permanent hair reduction.
The diode laser system is intended for use on all skin types I-VI), including tanned skin.
�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden
2013.04.19 16:22:03 -04'00'
(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123483
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