(308 days)
No
The summary describes a standard diode laser for hair removal and does not mention any AI or ML components or functionalities.
No
The device is described as being for "hair removal" and "permanent hair reduction," which are cosmetic applications rather than treating a disease or medical condition.
No
The device is a diode laser for hair removal, intended for hair removal and permanent hair reduction. Its function is to reduce hair growth, not to diagnose a condition or disease.
No
The device description explicitly lists hardware components such as semiconductor solid-state lasers, switching power supply, laser power, treatment handle, key switch, and cooling system, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 description clearly states the device is a "diode laser for hair removal." It uses a laser to target hair follicles on the skin.
- Intended Use: The intended use is "hair removal, permanent hair reduction." This is a cosmetic or aesthetic procedure performed directly on the body, not an analysis of a specimen taken from the body.
- Device Description: The components listed (semiconductor lasers, power supply, treatment handle, cooling system) are typical for a laser device used for external treatment, not for analyzing biological samples.
The information provided strongly indicates this is a therapeutic or aesthetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Honkon's 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, 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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Axilla, Facial, Neck
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)
Not Found
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
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, 2013 | ||
| Beijing Honkon Technologies Co., Ltd. | ||
| Address: No.3 Building, No.11 Yard, Kangding Street, BDA, | ||
| 100176, Beijing, P.R.China | ||
| Primary Contact Person: | Mike Gu | |
| Regulatory Affairs Manager | ||
| OSMUNDA Medical Device Consulting Co., Ltd. | ||
| Tel: (+86) 20 6232 1333 | ||
| Fax: (+86) 208633 0253 | ||
| Secondary Contact Person: | Li Zhao | |
| Management Representative | ||
| Beijing Honkon Technologies Co., Ltd. | ||
| Tel: (+86) 10-56370050 | ||
| Fax: (+86) 10-56370076-610 | ||
| Trade Name: | ||
| Common/Usual Name: | ||
| Classification Names: | Diode Laser for Hair Removal | |
| Diode Laser | ||
| Powered Laser Surgical Instrument | ||
| Regulation number | 878.4810 | |
| Product Code: | GEX | |
| Predicate Device(s): | ||
| Device Description: | K112031 | |
| 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:
| 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 province
8656801270 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--------------------------------------------------------------------------------------------------|
| 808HGG
The 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 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 |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology: | The principle of laser hair removal is selective photothermolysis, the
matching of a specific wavelength of light and pulse duration to obtain
optimal effect on a targeted tissue with minimal effect on surrounding
tissue. Laser can cause localized damage by selectively heating melanin
and 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 is | ||
| intended for hair | ||
| removal, permanent hair | ||
| reduction. (Fitzpatrick | ||
| skin types I-VI), including | ||
| tanned skin. | 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 | ||
| Wavelength | ||
| (nm) | 810 | 808 |
| Output power | ||
| (W) | 30 | 30 |
| Fluence (Energy | ||
| Density) | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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