(308 days)
The diode laser for hair removal is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). 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.
The diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is described in the table below:
The provided text describes a 510(k) premarket notification for a "Diode Laser for Hair Removal" (K131838) and references a predicate device (K112031). However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any details related to AI performance, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
The document primarily focuses on establishing substantial equivalence to the predicate device based on technical specifications and intended use. The table provided in the input is a comparison of the Honkon device's technical specifications to those of the predicate device (Alma Lasers 810nm Diode Laser System with HR Mode).
Therefore, I cannot fulfill the request for information on acceptance criteria, a proving study, sample sizes, expert details, or ground truth, as none of this information is present in the provided text.
Here's an output reflecting what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, it compares the technical specifications and intended use of the proposed device to a predicate device to establish substantial equivalence. The "performance" is implied by meeting similar specifications.
| Parameter | Predicate Device (K112031) Alma Lasers | Proposed Device (K131838) Honkon Diode Laser |
|---|---|---|
| Intended Use | Hair removal, permanent hair reduction (Fitzpatrick skin types I-VI), including tanned skin. | Hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). Permanent hair reduction defined as long-term, stable reduction measured at 6, 9, and 12 months post-treatment. |
| Wavelength (nm) | 810 nm | 808 nm |
| Output power (W) | 30 W | 30 W |
| Fluence (Energy Density) | <120 J/cm² | <120 J/cm² |
| Pulse Duration | 5-200 ms | 5-300 ms |
| Frequency | Up to 10 Hz | 1-10 Hz |
| Spot Size | 12 cm² | 12 mm² |
| Material | Sapphire | Sapphire |
| Cooling | Contact cooling | Contact cooling |
| Anatomical Sites | Axilla, Facial, Neck | Axilla, Facial, Neck |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-1-2 | Comply with IEC 60601-1 and IEC 60601-1-2 |
| Radiation Safety | Comply with IEC 60601-2-22, IEC 60825-1 and 21 CFR 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS | Comply with IEC 60601-2-22, IEC 60825-1 and 21 CFR 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is based on a technical comparison to a predicate device, not on clinical trial data with test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. There is no mention of expert involvement in establishing a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document. The device is a diode laser for hair removal, not an AI-assisted diagnostic tool, and therefore MRMC studies with human readers are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical laser system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. No specific ground truth establishment method is described for performance evaluation. The substantial equivalence is based on technical specifications and intended use alignment with the predicate device. The intended use for "permanent hair reduction" is 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," which implies an outcomes-based ground truth for clinical efficacy, but the document does not present any study data to demonstrate this for the proposed device.
8. The sample size for the training set
This information is not provided in the document. The device is not an AI algorithm with a training set.
9. How the ground truth for the training set was established
This information is not provided in the document. Not applicable as there is no training set mentioned for an AI device.
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K131838
| Image: HONKON logo and Beijing company name | ||
|---|---|---|
| 510(k) Premarket Notification Submission | ||
| 510(k) Summary | APR 2 4 2014 | |
| Date:Submitter: | In accordance with 21 CFR 807.92 the following summary of information is provided:18 June, 2013Beijing Honkon Technologies Co., Ltd.Address: No.3 Building, No.11 Yard, Kangding Street, BDA,100176, Beijing, P.R.China | |
| Primary Contact Person: | Mike GuRegulatory Affairs ManagerOSMUNDA Medical Device Consulting Co., Ltd.Tel: (+86) 20 6232 1333Fax: (+86) 208633 0253 | |
| Secondary Contact Person: | Li ZhaoManagement RepresentativeBeijing Honkon Technologies Co., Ltd.Tel: (+86) 10-56370050Fax: (+86) 10-56370076-610 | |
| Trade Name:Common/Usual Name:Classification Names: | Diode Laser for Hair RemovalDiode LaserPowered Laser Surgical Instrument | |
| Regulation number | 878.4810 | |
| Product Code: | GEX | |
| Predicate Device(s):Device Description: | K112031The diode laser for hair removal is generally included components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, cooling system and accessories. Its models are 808CL, 808CM, 808CH, 808EH, 808BL, 808BM, 808BH, 808FH, 808HGG and 808DH. Theirs differences are between the size of device which is |
described in the table below:
| Model | Dimension (width* length* high) mm | |
|---|---|---|
| Before package | After package | |
| 808CL | 8155301420 | 8955901510 |
| 808CM | 7905401300 | 8706002200 |
| 808CH | 7755101395- | 8555701485 |
| 808EH | 8105301060 | 8905701960 |
| 808BL | 8105501300 | 8906101390 |
| 808BM | 8205901210 | 9006501300 |
| 808BH | 8205901280 | 9006501370 |
| 808DH | 7806201110 | 8606801200 |
Confidential and Privileged. This document confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved
{1}------------------------------------------------
HONKON
气安星激光技术有限公司
510(k) Premarket Notification Submission
Proposed device
Technologies Co., Ltd
808CH, 808EH, 808BL,
808FH, 808HGG
Honkon
808CM,
808BH,
Modified
Treatment
Module
Beijing
808CL,
808BM,
| 808FH | 7856201180 | arrange a datt - a sua man a manufacturer and any final possible of the province8656801270 |
|---|---|---|
| 808HGGThe first from the may in the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of the coun | 7806301290 | 8606901380 |
| Intended Use: | The Honkon's diode laser for hair removal is intended for hairremoval, permanent hair reduction on all skin types (Fitzpatrickskin type I-VI).Permanent hair reduction is defined as the long-term, stablereduction in the number of hairs regrowing when measured at 6,9 and 12 months after the completion of a treatment regime |
|---|---|
| Technology: | The principle of laser hair removal is selective photothermolysis, thematching of a specific wavelength of light and pulse duration to obtainoptimal effect on a targeted tissue with minimal effect on surroundingtissue. Laser can cause localized damage by selectively heating melaninand follicle while not heating the rest of the skin. |
| Determination of | Specification | Predicate Device |
|---|---|---|
| Substantial Equivalence: | ||
| K number | K112031 | |
| Manufacturer | Alma Lasers, Inc. |
Model
.
Confidential and Privileged. This document confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not be disclosed to others not employed by Beijing Honkon Technologics Co., Ltd. All rights reserved
Alma
Diode
with
Mode for
Lasers
HR
Laser
{2}------------------------------------------------
510(k) Premarket Notification Submission
| Intended Use | ||
|---|---|---|
| The HR Mode isintended for hairremoval, permanent hairreduction. (Fitzpatrickskin types I-VI), includingtanned skin. | The diode laser forhair removal isintended for hairremoval, permanenthair reduction on allskin types (Fitzpatrickskin type I-VI).Permanent hairreduction is definedas the long-term,stable reduction inthe number of hairsregrowing whenmeasured at 6, 9 and12 months after thecompletion of atreatment regime | |
| Wavelength(nm) | 810 | 808 |
| Output power(W) | 30 | 30 |
| Fluence (EnergyDensity) | <120 J/cm² | <120 J/cm² |
| Pulse Duration | 5-200ms | 5-300 ms |
| Frequency | Up to 10Hz | 1-10Hz |
| Spot Size | 12cm² | 12mm² |
| Material | Sapphire | Sapphire |
| Cooling | Contact cooling | Contact cooling |
| Anatomical Sites | Axilla, Facial, Neck | Axilla, Facial, Neck |
| Electrical Safety | Comply with IEC 60601-1 and IEC 60601-1-2 | Comply with IEC60601-1 and IEC60601-1-2 |
| Radiation Safety | Comply with IEC 60601-2-22, IEC 60825-1 and 21CFR 1040PERFORMANCESTANDARDS FOR LIGHT-EMITTING PRODUCTS | Comply with IEC60601-2-22, IEC60825-1 and 21 CFR1040 PERFORMANCESTANDARDS FORLIGHT-EMITTINGPRODUCTS |
Confidential and Privileged. This document confidential and priviteged trade secrets and other information of Beijing Connection and Printegor. The Locallion Called on thers not printers and soles and Ministman of Colling Honkon i'cchnologies Co., Ltd. All
rights reserved
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "HONKON" in bold, black letters. Below the word "HONKON" is a line of Chinese characters. The characters appear to be a company name.
510(k) Premarket Notification Submission
Conclusion:
The Diode Laser for Hair Removaland its application comply with standards as detailed in section 9, 11 and 17 of this premarket notification. Therefore, Beijing Honkonstatesthat the non-clinical tests determined that the Diode Laser for Hair Removal to be as safe, as effective and performance is substantially equivalent to the predicate device(s).
Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of Beijing Honkon Technologies Co., Ltd. and as such may not employed by Beijing Honkon Technologies Co., Ltd. All rights reserved
{4}------------------------------------------------
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or a caduceus-like design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Osmunda Medical Device Consulting Company, Ltd. Mr. Mike Gu Regulatory Affairs Manager 7th floor, Jingui Business Building, 982 Congyun Road Baiyun District, 510420, Guangzhou, China
Re: K131838
Trade/Device Name: 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: II Product Code: GEX Dated: March 25, 2014 Received: March 27, 2015
Dear Mr. Gu:
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. Iisting 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 801); medical device reporting (reporting of medical
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
{5}------------------------------------------------
Page 2 - Mr. Mike Gu
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S.
- Acting Director
- Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131838
Device Name Diode Laser for Hair Removal
Indications for Use (Describe)
The diode laser for hair removal, permanent hair reduction on all skin types (Fitzpatick skin type I-V).
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden 2014.04.23 15:34:14
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
{7}------------------------------------------------
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ﺍﻟﻤﺮﺍﺟﻊ
§ 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.