(97 days)
Not Found
No
The summary describes a standard diode laser hair removal device with a skin contact sensor and cooling feature. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended for hair removal and permanent hair regrowth reduction, which is a cosmetic purpose rather than a diagnosis, cure, mitigation, treatment, or prevention of disease.
No
Explanation: The device description and intended use clearly state that it is for hair removal, a therapeutic or cosmetic purpose, not for diagnosing any condition.
No
The device description explicitly details hardware components such as a laser emitter, sensor, skin cooling feature, and external power adaptor. It also mentions electrical, EMC, and laser output safety and performance testing, which are relevant to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Diode Laser Hair Removal device described here works by emitting laser light that interacts directly with hair follicles on the skin. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for hair removal and permanent reduction in hair regrowth, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The description clearly indicates a device that applies energy to the body for a physical effect, which falls under the category of therapeutic or aesthetic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Har Removal is also intended 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 regime.
Product codes
OHT
Device Description
The Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810mm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
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
over-the-counter
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
The following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of Diode Laser Hair Removal was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing was performed to, and passed, including:
- ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10:2010, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
- Electrical, EMC, and laser output, Safety and Performance Testing: Electrical, EMC, and laser output, Safety and Performance Testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
- IEC 60601-2-22 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 Safety of laser products Part 1: Equipment classification, and requirements
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
April 19, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Wuhan Lotuxs Technology Co., Ltd. % Na Wu Management Representative Tacro Guangzhou Branch 501/E2. Future city. No.999 High-Tech Avenue (Free Trade Zone/Wuhan Area) Wuhan, 430206 China
Re: K230090
Trade/Device Name: Diode Laser Hair Removal 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: OHT Dated: January 4, 2023 Received: January 12, 2023
Dear Na Wu:
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.
1
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 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.
Colin K. Chen -S
for
Jianting Wang 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) K230090
Device Name Diode Laser Hair Removal
Indications for Use (Describe)
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Har Removal is also intended 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 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) |
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3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2023-04-14
I. Submitter
Wuhan Lotuxs Technology Co.,Ltd. 501/E2, Future city, No.999 high-tech Avenue, Wuhan 430206, China(Free Trade Zone/Wuhan Area) Tel.: +86 -27-87619668
Na Wu (Management Representative) Tel: +86 13871252776 Email: na.wu@lotuxs.com
II. Correspondent Consultant
Tacro Guangzhou Branch Rm. 501, No.55 West Tiyu Rd., Tianhe Dist., Guangzhou, Guangdong
Gamma Zhang(RA manager) Tel: +86 13433933949 Email: wbzhang@tacro.cn
III. Device
Type of 510(k): Traditional Common Name: Powered laser surgical instrument Trade Name: Diode Laser Hair Removal Model: LHR-V8S-810, LHR-V8-810, LHR-V4S-810, LHR-V4-810 Classification Name: Light Based Over-The-Counter Hair Removal Regulation Number: 21 CFR 878.4810 Review Panel: General & Plastic Surgery Regulatory Class: II Product Code: OHT
IV. Predicate Device
| Applicant | Predicate Device | 510(k) Number |
|---|---|---|
| Wuhan Lotuxs | ||
| Technology | ||
| Company, Ltd. | SILKPRO Laser Hair | |
| Removal System | K142845 |
4
510(k)s-Section 6. 510(k) Summary
V. Device Description
The Diode Laser Hair Removal device models LHR-V8S-810, LHR-V8-810, LHR-V4S-810, and LHR-V4-810 emit pulses of invisible infrared laser light of 810mm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
VI. Indications for Use
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. SILKPRO is also intended 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 regime.
VII.Comparison of Technological Characteristics With the Predicate Device
| Comparison
| Elements | Subject Device | Predicate Device |
|---|---|---|
| K Number | Applying | K142845 |
| Trade name | Diode Laser Hair Removal | SILKPRO Laser Hair Removal System |
| Model | LHR-V8S-810, LHR-V8-810, LHR-V4S-810, LHR-V4-810 | / |
| Classification name | Light Based Over-The-Counter Hair Removal | Light Based Over-The-Counter Hair Removal |
| Product code | OHT | OHT |
| Intended | ||
| use/Indications for | ||
| Use | Diode Laser Hair Removal is an over-the-counter device intended for | |
| adjunctive use with shaving for hair removal sustained with periodic | ||
| treatments. Diode Laser Hair Removal is also intended 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 regime. | SILKPRO is an over-the-counter device intended for adjunctive use with shaving | |
| for hair removal sustained with periodic treatments. SILKPRO is also intended 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 regime. | ||
| Laser Type | Diode laser | Diode laser |
| Laser Material | GaAs | GaAs |
| Wavelength | 810nm | 810nm |
| Max Energy Density | LHR-V8S-810, LHR-V8-810: 9.0J/cm² | |
| LHR-V4S-810, LHR-V4-810: 7.0J/cm² | 25J/cm² |
A technical comparison to the predicate is provided below:
5
| Comparison
| Elements | Subject Device | Predicate Device |
|---|---|---|
| Energy Density | LHR-V8S-810, LHR-V8-810: 2.2J/cm2, | |
| 3.4J/cm2, 4.5J/cm2, 5.6J/cm2, 7.0J/cm2, | ||
| 9.0J/cm2 | 5J/cm2, 10J/cm2, 15J/cm2, | |
| LHR-V4S-810, LHR-V4-810: 2.0J/cm2, 2.8J/cm2, 3.5J/cm2, 4.3J/cm2, 5.3J/cm2, 7.0J/cm2 | 20J/cm2, 25J/cm2 | |
| Treatment Window | ||
| Size | 30mm×10mm | 9mm×9mm |
| Safety feature | Complied with IEC 60601-1, | |
| IEC 60601-1-11, IEC60601-1- | ||
| 2, IEC 60601-2-22 and IEC | ||
| 60825-1 | Complied with IEC 60601-1, | |
| IEC 60601-1-11, IEC60601-1- | ||
| 2, IEC 60601-2-22 and IEC | ||
| 60825-1 | ||
| Biocompatibility | All body-contacting materials | |
| are complied with ISO10993-5 | ||
| and ISO 10993-10 | All body-contacting materials | |
| are complied with ISO10993-5 | ||
| and ISO 10993-10 |
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1)Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of Diode Laser Hair Removal was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on June 16, 2016", as recognized by FDA. The testing was performed to, and passed, including:
-
ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization
2)Electrical, EMC, and laser output, Safety and Performance Testing
Electrical, EMC, and laser output, Safety and Performance Testing was performed to, and passed, the following standards:
6
510(k)s-Section 6. 510(k) Summary
-
IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
-
IEC 60601-2-22 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 Safety of laser products Part 1: Equipment classification, and requirements
Summary
Based on the above performance as documented in this application, Diode Laser Hair Removal was found to have a safety and effectiveness profile that is same as the predicate device.
VIII. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, Diode Laser Hair Removal is considered to be substantially equivalent to the predicate device K142845.