(87 days)
No
The summary describes a standard laser hair removal device based on selective photothermolysis and does not mention any AI or ML components in the device description, intended use, or performance studies.
No.
The device's intended use is for permanent reduction in hair regrowth, which is generally considered a cosmetic procedure aiming for aesthetic improvement rather than treating a disease or injury.
No
The device is described as a Diode Laser Therapy Device used for hair reduction, which is a therapeutic rather than a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a power supply system, delivery system, control system, cooling system, laser system, and handpieces. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent reduction in hair regrowth" by applying laser energy to the skin. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a laser system designed to deliver energy to the skin for hair removal. It does not mention any components or processes related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed 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 Device 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.
Product codes
GEX
Device Description
The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.
The proposed device includes power supply system, delivery system, control system, cooling system, laser system.
The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
April 17, 2020
Shanghai Apolo Medical Technology Co., Ltd. Ms. Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Jingan District Shanghai. 200071 CN
Re: K200118
Trade/Device Name: Diode Laser Therapy Device 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 15, 2020 Received: January 21, 2020
Dear Claire Zhang:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Colin Kejing Chen 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
2
Indications for Use
510(k) Number (if known) K200118
Device Name Diode Laser Therapy Devices
Indications for Use (Describe)
The Diode Laser Therapy Device 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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3
K200118-510(k) summary
l Submitter
Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China Preparation Date: Apr.16, 2020
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: | Diode Laser Therapy Device |
|---|---|
| Common name: | Powered Laser Surgical Instrument |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | GEX |
| Review Panel | General & Plastic Surgery |
III Predicate Devices
| 510(k) Number: | K172193 |
|---|---|
| Trade name: | Modified Alma Lasers Soprano XL™Family of |
| Multi-Application and Multi-Technology Platforms | |
| [SopranoXL, SopranoXLi, Soprano ICE and Soprano ICE Platinum] with Trio Diode LaserModule | |
| Common name: | Powered Laser Surgical Instrument |
| Classification: | Class II |
| Product Code: | GEX |
| Manufacturer | Alma Lasers Inc. |
IV Device description
The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective
4
photothermolysis. The wavelength of 810nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.
The proposed device includes power supply system, delivery system, control system, cooling system, laser system.
The 755nm, 810nm, 1064nm handpieces with different treatment size are available for different models.
V Indication for use
The Diode Laser Therapy Device 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.
| Item | Proposed device | Predicate device
(K172193) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Diode Laser Therapy Device | Modified Alma Lasers
Soprano XL™Family of
Multi-Application and
Multi-Technology
Platforms [SopranoXL,
SopranoXLi, Soprano
ICE and Soprano ICE
Platinum] with Trio
Diode LaserModule |
| Product Code | GEX | GEX |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Class | Class II | Class II |
| Indication for use | The Diode Laser Therapy Device 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 | Intended use:
The device is intended
for use in dermatologic
and general surgical
procedures.
Indication for use: |
| type I-VI), including tanned skin. | The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include: Benign vascular and vascular dependent lesions removal. The indications for use for the Soprano 1064nm 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. Treatment of Pseudo folliculitis Barbae (PFB) Use on all skin types (Fitzpatrick I-VI), including tanned skin | |
| | The indications for use
for the 810nm Modified
Diode Laser Module
1.2cm² 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.
• The treatment of
benign vascular and
pigmented
lesions.(The Laser
Blanch (LB) Mode)
• Use on all skin
types (Fitzpatrick
I-VI), including
tanned skin. (HR,
SHR and LB
Modes)
Optional Tapered Light
Guide: It is intended for
the same use as the
device.
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) 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.
The treatment of
benign vascular and
pigmented
lesions.(The Laser
Blanch Mode)
Use on all skin
●
types (Fitzpatrick
I-VI),
including
tanned to a
skin. (HR, | |
| | SHR and Laser
Blanch Modes) | |
| | NIR Modules
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 The
temporary
●
increase in local
circulation where
applied, and | |
| | The relaxation of
muscles; may also
help
muscle
spasms,
minor | |
VI Comparison of technological characteristics with the predicate devices
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6
7
8
9
| sprains and strains, and minor muscular back pain. | |||||
|---|---|---|---|---|---|
| Laser | |||||
| Type | Solid state | Solid state | |||
| Light | |||||
| Delivery | |||||
| system | 755nm handpiece | ||||
| 810nm handpiece | |||||
| 1064nm handpiece | 755nm module | ||||
| 810nm module | |||||
| 1064nm module | |||||
| Soprano trio diode laser module | |||||
| NIR Modules | |||||
| Handpiece tip | |||||
| material | Sapphire | Sapphire | |||
| Controls | Footswitch or handpiece | Footswitch or handpiece | |||
| Handpiece | HS-810N & 811N | HS-812N | HS-816 & 818 | HS-817 & 819 | Soptano titanium |
| Spot size | 12x18m; | ||||
| 12x30 mm; | 12x20mm; | ||||
| 15x40 mm; | 12x14m; | ||||
| 10x10 mm | 12x16m; | ||||
| 12x20 mm | ALEX 755nm handpiece: 15 x10mm; | ||||
| Speed 810nm handpiece 20 x10mm | |||||
| Trio handpiece:2cm². | |||||
| Energy | |||||
| density | 1~110J/cm² | 1~62J/cm² | |||
| 1~40 J/cm² | 1~72J/cm² | ||||
| 1~60J/cm² | 1~62J/cm² | ||||
| 1~64 J/cm² | 120J/ cm², 150J/cm² (optional). | ||||
| Pulse | |||||
| width | 10-400ms | 10-300ms; | |||
| 1-200ms. | 1-200ms; | ||||
| 1-100ms | 10-300ms | 810,755nm: 3.3~200; | |||
| 1064nm: 3.3~280 | |||||
| Trio:40-800ms | |||||
| Pulse | |||||
| frequency | 1, 2, 3, 5, 8, 10HZ. | 1,2,3,5,8, 10,15HZ | 1,2,3,5, 8,10,15 Hz | 1,2,3,5, 8,10Hz | 810,755nm: 0.5 |
| 1064nm: 0.5 | |||||
| Trio:40-800ms,Up to 10Hz. | |||||
| Wavelength | 755nm/810nm/1064nm for option | 755nm/810nm/1064nm |
10
| gth | | and three in one for
option |
|-------------------------|-----------------------|--------------------------------|
| Operation
interface | LCD color Touchscreen | LCD color Touchscreen |
| Laser
classification | Class IV | Class IV |
| Software | Yes | Yes |
The indication of proposed device is covered by the predicated device. The proposed device is only intended to use for hair removal. The device includes seven models for clearance in this submission. The differences between models are the treatment area, laser energy density, pulse frequency, pulse width. These are covered by the predicated device. The different wavelengths (755nm/810nm/1064nm) are available for all models. The proposed device does not have NIR Modules or Trio Diode Laser modules (combining wavelengths) compared to the predicate device. The minor differences in indication do not alter the use of the proposed device.
VII Non-Clinical Testing
A battery of tests has been performed to verify 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 -Part 1-2: 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(third edition)+A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition)+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility
The patient contact component of the device was performed the Biocompatibility
11
testing and reference standards as following testing:
- Cytotoxicity . ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity
- Sensitization ISO 10993-10:2010, ● Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization.
- . Irritation ISO 10993-10:2010, Biocompatibility Evaluation of Medical Device - Part 10: Tests for Irritation and Shin Sensitization.
VIII Clinical Testing
It is not applicable.
IX Conclusion
The performance testing and software validation testing determined that the subject device is substantially equivalent to the predicate device.