(237 days)
Not Found
No
The summary describes a laser therapy system based on selective photothermal interaction and provides technical specifications related to wavelengths and device types. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in the provided text.
No
The device is indicated for temporary or permanent hair reduction, which is generally considered a cosmetic procedure, not a therapeutic one that treats a disease or condition.
No
Explanation: The device is a Diode Laser Therapy System indicated for hair reduction, not for diagnosing medical conditions. Its function is to deliver laser energy to achieve temporary or permanent hair reduction.
No
The device description explicitly states it consists of a main unit, handpiece, and accessories, and is a laser therapy system, indicating it is a hardware device with potential software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The provided description clearly states that the Diode Laser Therapy System is used for hair reduction by applying laser energy directly to the skin. This is a physical treatment performed on the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical components or processes associated with IVDs, such as reagents, sample collection, laboratory analysis, or diagnostic results.
The device is a therapeutic device used for a cosmetic/medical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
The Diode Laser Therapy System(Model: FG2000-D+Fro/FG2000-E) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.
The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.
The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
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 subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
IEC60601-1:2005, AMD1:2012, AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AAMI ES60601-1:2005, ES60601-1:2005/AMD1 1:2012, ES60601-1:2005/AMD2:2021 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 /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems IEC 60601-2-22:2007 + A1:2012 +A2:2019 Medical Electrical Equipment - Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1:2014 (Third Edition) Safety of laser products - Part 1: Equipment classification, and requirements
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 20, 2024
Beijing ADSS Development Co., Ltd. Song Ying International Registration Manager Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing, 102600 China
Re: K231896
Trade/Device Name: Diode Laser Therapy 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: GEX Dated: January 17, 2024 Received: January 18, 2024
Dear Song Ying:
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.
1
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 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-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 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.
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-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,
Shlomit Halachmi
Digitally signed by Shlomit Shlomit Halachmi -S Halachmi -S Date: 2024.02.20 18:39:10-05'00'
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231896
Device Name Diode Laser Therapy System
Indications for Use (Describe)
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
| 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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4
510(k) Summary
Submission Number: K231896
1. Submitter's Information
Establishment Registration Information
Beijing ADSS Development Co., Ltd.
Room 609, F6, Building 13, Yard 5 Tianhua Street, Daxing District, Beijing, 102600, P. R. China
Contact Person of applicant Name: Song Ying International Registration Manager TEL: +86 13051615111 Email: irm@adss.com.cn Summary Preparation date: February 18, 2024
2. Device Information
| Trade Name: | Diode Laser Therapy System |
|---|---|
| Model: | FG2000-B/FG2000-B Pro/FG2000-D+/FG2000-D+Pro/ FG2000-E |
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Product code: | GEX |
| Regulation Class: | Class II |
| Review panel: | General & Plastic Surgery |
3. Predicate Device Information
Predicate Device of Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) 510(K) Number: K230371 Trade Name: Alma Soprano Titanium Manufacturer: Alma Lasers Inc.
Predicate Device of Diode Laser Therapy System (Model: FG2000-D+Pro/ FG2000-D+Pro/ FG2000-E) 510(K) Number: K220381 Trade Name: Diode Laser Therapy Systems Beijing LaserTell Medical Co., Ltd Manufacturer:
5
4. Device description
The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base.
The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction.
The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
5. Indications for Use
The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction.
The Diode Laser Therapy System(Model: FG2000-D+Fro/FG2000-E) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
6. Summary of technological characteristics of device compared to the predicate device
| Item | Subject device | Predicate device
(K230371) | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Device Name | Diode Laser Therapy
System | Alma Soprano Titanium | / |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | Class II | Class II | SE |
| Product Code | GEX | GEX | SE |
| Indication for
use | The Diode Laser Therapy
System is indicated for
temporary hair reduction. | The Soprano Titanium diode laser module is
intended for use in dermatology procedures
requiring coagulation.
The indications for use for the Soprano
Trio diode laser module include: | SE
The indication of
subject device is
covered by the
predicate device.
The subject |
| | The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. | device is only intended to use for temporary hair reduction. | |
| | The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. | | |
| | 810nm Applicator
Soprano Titanium 810 nm applicator intended use and indications for use:
The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes) | | |
| | 755nm applicator
Soprano Titanium 755 nm applicator intended use and indications for use:
The indications for use for the 755nm Diode Laser Module include:
• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes) | | |
| | NIR Applicator
NIR Applicator intended use and indications for use
The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) | | |
| | | | |
| | | spectrum to provide topical heating.
The indications for use for NIR Modules are:
• Elevating the tissue temperature for the
temporary relief of minor muscle pain and joint
pain and stiffness,
• The temporary relief of minor joint pain
associated with arthritis,
• The temporary increase in local circulation
where applied, and
• The relaxation of muscles; may also help
muscle spasms, minor sprains and strains, and
minor muscular back pain. | |
| Laser Type | Diode laser | Diode laser | SE |
| Laser
Classification | Class IV | Class IV | SE |
| Laser
Wavelength | combination of
755nm/808nm/1064nm | combination of 755nm/810nm/1064nm | SE |
| Spot size | 12×16 mmmm(1.92cm²) | 2010 mmmm (2cm²); | Different 1. |
| Pulse width | up to 200ms | Up to 200ms | SE |
| Energy
fluence | 28J/cm2 | 2 to 8J/cm2 | SE |10Hz | up to 10 Hz | SE |
| Pulse
frequency | 1
| User
interface | LCD Color Touchscreen | LCD Color Touchscreen | SE |
| Electrical
Safety | Comply with ANSI/AAMA
ES 60601-1,
IEC 60601-2-22 | Comply with ANSI/AAMA ES 60601-1,
IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-
2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-
22,
IEC 60825-1 | Comply with IEC 60601-2-22,
IEC 60825-1 | SE |
| Handpiece tip
material | Quartz crystal | Sapphire | SE |
| Cytotoxicity | comply with ISO 10993-
5:2009 | comply with ISO 10993-5:2009 | SE |
| Sensitization | comply with ISO 10993-
10:2021 | comply with ISO 10993-10:2010 | SE |
| Irritation | comply with ISO 10993-23:
2021 | comply with ISO 10993-10:2010 | SE |
| Item | Subject device | Predicate device (K220381) | Comparison |
| Device
Name | Diode Laser Therapy System | Diode Laser Therapy Systems | / |
| Regulation
Number | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | Class II | Class II | SE |
| Product
Code | GEX | GEX | SE |
| Indication for
use | The Diode Laser Therapy System
is indicated for permanent
reduction in hair regrowth defined
as a long term, stable reduction in
the number of hairs re-growing
when measured at 6,9 and 12
months after the completion of a
treatment regimen. It is suitable for
all skin types (Fitzpatrick skin type
I-VI), including tanned skin. | The Diode Laser Therapy Systems
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. | SE |
| Laser Type | Diode laser | Diode laser | SE |
| Laser
Classification | Class IV | Class IV | SE |
| Laser
Wavelength | 808nm | 808nm | SE |
| Spot size | 10×10mmmm | 15x15mm*mm; | Different 1 |
| Pulse width | 2～100ms | 1-300ms | Different 2 |
| Energy
fluence | 2～100J/cm2 | 1～100J/cm2 | Different 3 |
| Pulse
frequency | 110Hz | 110Hz | SE |
| User
interface | LCD Color Touchscreen | LCD Color Touchscreen | SE |
| Electrical
Safety | Comply with
ANSI/AAMA ES 60601-1,
IEC 60601-2-22 | Comply with
ANSI/AAMA ES 60601-1,
IEC 60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22,
IEC 60825-1 | Comply with IEC 60601-2-22,
IEC 60825-1 | SE |
| Handpiece
tip materia | Quartz crystal | Sapphire | SE |
| Cytotoxicity | comply with ISO 10993-5:2009 | comply with ISO 10993-5:2009 | SE |
| Sensitization | comply with ISO 10993-10:2021 | comply with ISO 10993-10:2010 | SE |
| Irritation | comply with ISO 10993-23: 2021 | comply with ISO 10993-10:2010 | SE |
6.1 For Model: FG2000-B/FG2000-B Pro
6
7
8
6.2 For Model: FG2000-D+/FG2000-D+Pro/FG2000-E
9
7. Non-Clinical Tests Performed for Safety and effectiveness
Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
IEC60601-1:2005, AMD1:2012, AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
AAMI ES60601-1:2005, ES60601-1:2005/AMD1 1:2012, ES60601-1:2005/AMD2:2021 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 /TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems IEC 60601-2-22:2007 + A1:2012 +A2:2019 Medical Electrical Equipment - Part 2: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1:2014 (Third Edition) Safety of laser products - Part 1: Equipment classification, and requirements
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10: 2021 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation.
8. Clinical Testing Performed
There was no clinical testing performed.
9. Conclusions
The subject device Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) have the similar intended use and similar characteristics as the cleared predicate device. And the bench testing contained in this submission supplied demonstrate that the differences existed do not raise any new questions of safety or effectiveness. Thus, subject device Diode Laser Therapy System is Substantially Equivalent (SE) to the predicate device(Alma Soprano Titanium, K230371).
The subject device Diode Laser Therapy System (Model: FG2000-D+FG2000-D+Pro/FG2000-E) have the same intended use and similar characteristics as the cleared predicate device. And the bench testing contained in this submission supplied demonstrate that the differences existed do not raise any
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new questions of safety or effectiveness. Thus, subject device Diode Laser Therapy System is Substantially Equivalent (SE) to the predicate device (K220381).