(86 days)
Not Found
No
The summary describes a standard diode laser hair removal device based on selective photothermolysis. There is no mention of AI, ML, image processing, or any data training/testing related to algorithmic performance. The performance studies focus on electrical safety, laser safety, biological evaluation, spot size accuracy, and usability/label comprehension, not AI/ML model validation.
Yes.
The device is intended for "permanent reduction in hair regrowth" through long-term, stable reduction in hair counts, which is a physiological effect on the body and indicates a therapeutic purpose.
No
This device is intended for hair removal and permanent hair reduction. It does not perform any diagnostic function.
No
The device description explicitly states it is a "semiconductor diode laser system" and describes its physical characteristics and mechanism of action (delivering infrared light at a specific wavelength). This indicates it is a hardware device, not software only.
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 reduction in hair regrowth. This is a physical treatment applied to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a laser system that delivers infrared light to target hair follicles. This is a therapeutic or cosmetic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on safety standards, usability, and accuracy of the laser's physical characteristics (spot size). There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
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 Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permant hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
Product codes
OHT
Device Description
The Handheld Diode Laser for Hair Removal is an Over-The-Counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. The device is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime permanent hair reduction is defined as long term, stale reduction in the number of hairs regrowing when measured out of 6, 9, and 12 months after the completion of the treatment regimen.
The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm.
Laser hair removal is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.
Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.
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 device
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
A Usability/Label Comprehension Study was conducted.
Two smaller groups out of these participants were chosen to participate in a usability study in which the actual product along with its labeling would be tested.
The first group of 13 participants consisted of 7 females, 6 males and their ages ranged from 19-71 years. Two participants with dark skin tone and one participant with blond hair were included in this group. It was explained to them what the study was all about and then were asked (two at a time) to pretend that they had just purchased the product and were to use it for the first.
The tester allowed ample time for the users to read/study the labeling, include information on retail box, name plate and Instruction Manual Rev: V 1.02, completely while recording questions and answering them. Then the actual use of the product was observed, remarks and questions were recorded.
Then we revised the Instruction Manual form Rev: V 1.03 according with the question from the tester.
A second group of 10 participants was chosen for a second test. There were 5 females, 5 males and their ages ranged between 19 and 73 years.
Again, after allowing ample time to read and study the Instruction Manual Rev: V 1.03, the questions asked came down to only 2 and they were not pertaining to safety or operation.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Usability/Label Comprehension Study.
First group (N=13): 7 females, 6 males, ages 19-71. Two participants with dark skin tone and one participant with blond hair.
- All participants understood the "Skin Tone Chart", Warnings, Indications and Contraindications;
- Three user refused to use the product after reading the determination as "Skin Tone Chart" and Indications, because skin tone and hair color;
- 9 of the remaining 10 users had questions.
The inputs of the first groups needed some changes and additions to the Instruction Manual (Rev: V 1.02).
Second group (N=10): 5 females, 5 males, ages 19-73.
All (100%) participants were able to properly use the device and properly clean it with the labeling submitted.
The inputs of the second test groups did not warrant any more changes and additions to the Instruction Manual (Rev: V 1.03).
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2017
Liaoning Sidey Optoelectronics Technologies Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju, No.25 Banbidian Rd., Liyuan Town, Tongzhou Beijing, 101121 CN
Re: K163173
Trade/Device Name: Handheld Diode Laser For 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: November 7, 2016 Received: November 14, 2016
Dear Ray Wang:
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
1
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 devicerelated 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 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,
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) K163173
Device Name Handheld Diode Laser for Hair Removal
Indications for Use (Describe)
The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permant hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
| Type of Use (Select one or both, as applicable) | Research involving HHS conducted or supported research Clinical Trial, Cooperative Agreement, HHS conducted or supported research | Research involving HHS conducted or supported research | Clinical Trial, Cooperative Agreement, HHS conducted or supported research |
|---|---|---|---|
| Research involving HHS conducted or supported research | |||
| Clinical Trial, Cooperative Agreement, HHS conducted or supported research |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Tab #7 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: __K163173
-
- Date of Preparation
11/07/2016
- Date of Preparation
-
Sponsor 2.
Liaoning Sidey Optoelectronics Technologies Co., Ltd.
No.6 Building,No.262 Yueling Rd,high-tech industrial development zone,114044,Anshan,Liaoning,China Establishment Registration Number: Not yet registered or the Number Contact Person: Li Zhao Position: Registration Manager Tel: +86-10-56370050 Fax: +86-10-56370076 Email: small@honkonlaser.com
- Submission Correspondent 3.
Mr. Ray Wang
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd.,
LiYuan Town, TongZhou District, Beijing, 101121, China
Tel: +86-10-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com
4
-
- Identification of Proposed Device
Trade Name: Handheld Diode Laser for Hair Removal Common Name: Light Based Over-The-Counter Hair Removal Model(s): SD-BD01
- Identification of Proposed Device
Regulatory Information:
Classification Name: Light Based Over-The-Counter Hair Removal Classification: II; Product Code: OHT; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;
Intended Use Statement:
The Handheld Diode Laser for Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Handheld Diode Laser for Hair Removal is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime. permanent hair reduction is defined as long term, stable reduction in the number of hairs regrowing when measured out to 6, 9, and 12 months after the completion of the treatment regimen.
న్. Device Description
The Handheld Diode Laser for Hair Removal is an Over-The-Counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. The device is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime permanent hair reduction is defined as long term, stale reduction in the number of hairs regrowing when measured out of 6, 9, and 12 months after the completion of the treatment regimen.
The Handheld Diode Laser for Hair Removal is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 808nm.
Laser hair removal is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue.
Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths.
5
-
- Identification of Predicate Device
Predicate 1#: 510(k) Number: K120737 Product Name: TRIA Laser Hair Removal System Manufacturer: Tria Beauty, Inc.
- Identification of Predicate Device
Predicate 2#: 510(k) Number: K142845 Product Name: SILKPRO Laser Hair Removal System Manufacturer: Wuhan Lotuxs Technology Company, Ltd.
-
- Non-Clinical Test Conclusion
Non clinical 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:
- Non-Clinical Test Conclusion
-
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
-
IEC 60601-2-22:2007, Medical Electrical Equipment Part 2-22: Particular Requirements For Basic > Safety And Essential Performance Of Surgical, Cosmetic And Diagnostic Laser Equipment;
-
IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification and requirements. A
-
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.
-
IEC 60601-1-11:2010, Medical electrical equipment - Part 1-11: General requirements for medical device equipment and medical electrical systems used in the home healthcare environment.
-
A 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
-
Performance Testing for Spot Size Accuracy.
A Usability/Label Comprehension Study was conducted.
Two smaller groups out of these participants were chosen to participate in a usability study in which the actual product along with its labeling would be tested.
The first group of 13 participants consisted of 7 females, 6 males and their ages ranged from 19-71 years. Two participants with dark skin tone and one participant with blond hair were included in this group. It was explained to them what the study was all about and then were asked (two at a time) to pretend that they had just purchased the product and were to use it for the first.
6
The tester allowed ample time for the users to read/study the labeling, include information on retail box, name plate and Instruction Manual Rev: V 1.02, completely while recording questions and answering them. Then the actual use of the product was observed, remarks and questions were recorded.
Then we revised the Instruction Manual form Rev: V 1.03 according with the question from the tester.
A second group of 10 participants was chosen for a second test. There were 5 females, 5 males and their ages ranged between 19 and 73 years.
Again, after allowing ample time to read and study the Instruction Manual Rev: V 1.03, the questions asked came down to only 2 and they were not pertaining to safety or operation.
Results
For the first groups,
-
- All participants understood the "Skin Tone Chart", Warnings, Indications and Contraindications;
-
- Three user refused to use the product after reading the determination as "Skin Tone Chart" and
- Indications, because skin tone and hair color;
-
- 9 of the remaining 10 users had questions.
The inputs of the first groups needed some changes and additions to the Instruction Manual (Rev: V 1.02). For the second groups, the result showed that all (100%) participants were able to properly use the device and properly clean it with the labeling submitted.
The inputs of the second test groups did not warrant any more changes and additions to the Instruction Manual (Rev: V 1.03).
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
7
9. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| K120737 | K142845 | |||
| Product Code | OHT | GEX | OHT | SE |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Intended Use | The Handheld Diode Laser for Hair | |||
| Removal is an over-the-counter | ||||
| device intended for adjunctive use | ||||
| with shaving for hair removal | ||||
| sustained with periodic treatments. | ||||
| Handheld Diode Laser for Hair | ||||
| Removal is also intended for | ||||
| permanent reduction in hair | ||||
| regrowth defined as a long-term, | ||||
| stable reduction in hair counts | ||||
| following a treatment regime. | ||||
| permanent hair reduction is defined | ||||
| as long term, stable reduction in the | ||||
| number of hairs regrowing when | ||||
| measured out to 6, 9, and 12 | ||||
| months after the completion of the | ||||
| treatment regimen. | The TRIA is an | |||
| over-the-counter device | ||||
| intended for adjunctive use | ||||
| with shaving for hair removal | ||||
| sustained with periodic | ||||
| treatments. TRIA is also | ||||
| intended for permanent | ||||
| reduction in hair regrowth | ||||
| defined as a long-term, stable | ||||
| reduction in hair counts | ||||
| following a treatment regime. | ||||
| permanent hair reduction is | ||||
| defined as long term, stable | ||||
| reduction in the number of | ||||
| hairs regrowing when | ||||
| measured out to 6, 9, and 12 | ||||
| months after the completion of | ||||
| the treatment regimen. | The 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 hair counts | ||||
| following a treatment regime. | ||||
| permanent hair reduction is | ||||
| defined as long term, stable | ||||
| reduction in the number of | ||||
| hairs regrowing when | ||||
| measured out to 6, 9, and 12 | ||||
| months after the completion of | ||||
| the treatment regimen. | SE | |||
| Prescription/OTC | OTC | OTC | OTC | SE |
| Principle of | ||||
| Operation | Diode Laser | Diode Laser | Diode Laser | SE |
Table 1 General Comparison
8
| Item | Proposed Device | Predicate Device | Predicate Device | Remark |
|---|---|---|---|---|
| K120737 | K142845 | |||
| Laser Type | Diode Laser | Diode Laser | Diode Laser | SE |
| Laser Classification | Class IV | Class IV | Class IV | SE |
| Laser Wavelength | 808 nm | 810 nm | 810 nm | SE |
| Spot Size | ∅9mm (Round) | ∅10mm (Round) | 9x9 mm | Discussion 1 |
| Fluence | 5.5 - 21.2 J/cm² | |||
| 5.5 J/cm², 11 J/cm², 16.5 J/cm², 21.2 J/cm² | 7-22 J/cm² | |||
| 6 J/cm², 10 J/cm², 14 J/cm², 18 J/cm², 22 J/cm² | 5 - 25 J/cm² | |||
| 5 J/cm², 10 J/cm², 15 J/cm², 20 J/cm², 25 J/cm² | SE | |||
| Discussion 2 | ||||
| Power Supply | AC 110V/50Hz-60Hz | 100-240 V 50/60Hz | 100-240 V 50/60Hz | SE |
Table 2 Performance Comparison
Discussion 1
The proposed device is different in Spot Size from the proposed devices' pulse duration range is cover the predicates' and both proposed device and predicate has same Fluence, this difference will not affect the substantially equivalency.
Discussion 2
The proposed device is different in fluence setting level from the proposed devices' pulse duration range is cover the predicates' and both proposed device and predicate has same Fluence, this difference will not affect the substantially equivalency.
9
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Patient Contact Materials and Biocompatibility | |||
| Patient Contact | |||
| Materials | Sapphire in handpiece and handpiece tip | ||
| (Stainless Steel) | Stainless steel and Sapphire in handpiece | SE | |
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | |
| Sensitization | No evidence of sensitization | SE | |
| Irritation | No evidence of irritation | ||
| EMC, Electrical and Laser Safety | |||
| Electrical Safety | Comply with IEC 60601-1, IEC | ||
| 60601-2-22 | Comply with IEC 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 | Comply with IEC 60601-2-22, IEC 60825 | SE |
Table 3 Safety Comparison
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.
- Substantially Equivalent (SE) Conclusion