(87 days)
No
The summary describes a standard diode laser hair removal system based on selective photothermolysis and cooling technology. There is no mention of AI, ML, image processing, or any data-driven algorithms for treatment planning or execution. The performance studies focus on electrical, laser, and biological safety standards, not algorithmic performance.
Yes
Laser hair removal, even for cosmetic purposes, is considered a therapeutic procedure as it aims to effect a permanent physiological change (hair reduction). The device is also regulated as a medical electrical equipment explicitly including "therapeutic" laser equipment (IEC 60601-2-22).
No
A diagnostic device identifies or characterizes a disease or condition. This device is specified for hair removal, which is a cosmetic procedure, not a diagnostic one.
No
The device description clearly details a hardware device utilizing a diode laser and cooling technology for hair removal, and the performance studies reference standards for electrical and laser equipment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal, permanent hair reduction". This is a therapeutic/cosmetic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system that interacts directly with the body (skin and hair follicles) using light and heat energy. This is an in-vivo application, not an in-vitro one (which involves testing outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly a therapeutic laser system for hair removal.
N/A
Intended Use / Indications for Use
The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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
808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.
Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical study is included in this submission.
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:
- IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.1 2020-09, Medical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
- IEC 60601-2-22: 2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 20, 2024
Beijing Sea Heart International Science And TechnologyCo.Ltd % Rav Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, 102401 China
Re: K240520
Trade/Device Name: Diode Laser Hair Removal System (SH-VD910) 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: February 23, 2024 Received: February 23, 2024
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 (the 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 available 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
1
Page 2 K240520 - Ray Wang
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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,
Digitally signed by Tanisha L. Digitally signed by Tanisha L. Hithe -S Hithe -S - Date: 2024.05.20 21:04:18 -04'00'
Tanisha Hithe 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
3
Indications for Use
Submission Number (if known)
K240520
Device Name
Diode Laser Hair Removal System (SH-VD910)
Indications for Use (Describe)
The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K240520 The assigned 510(k) Number:
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.
-
- Date of Submission: 2024/2/23
-
- Sponsor Identification
Beijing Sea Heart International Science And Technology Co., Ltd.
Room 4009, Building 4, Zhongke Jingwei Industrial Park, No. 8 Yongchang Middle Road, Economic and Technological Development Zone, Beijing, China
Contact Person: He Xiaoli Position: General Manager Tel: 010-87161306 Email: admin@seaheartbj.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com
-
- Identification of Proposed Device
Trade Name: Diode Laser Hair Removal System
- Identification of Proposed Device
Common Name: Powered Laser Surgical Instrument
Regulatory Information Classification Name: Powered Laser Surgical Instrument Classification: II
5
Product Code: GEX Regulation Number: 878.4810 Review Panel: General & Plastic Surgery
-
న్. Identification of Predicate Device(s)
510(k) Number: K162659 Product Name: Diode Laser Hair Removal System Manufacturer: Shandong Huamei Technology Co.,ltd. -
- Device Description:
808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.
- Device Description:
Diode Laser Hair Removal is the safest and fastest at the present. It adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal.
-
- Indication For Use Statement:
The Diode Laser Hair Removal System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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.
- Indication For Use Statement:
| Item | Proposed Device | Predicate Device K162659 | Remark |
|---|---|---|---|
| Device Name | Diode Laser Hair Removal System | Diode Laser Hair Removal System | / |
| Classification | |||
| Regulation | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Classification | |||
| Panel | General & Plastic | ||
| Surgery | General & Plastic Surgery | SAME | |
| Class | II | II | SAME |
| Product Code | GEX | GEX | SAME |
| Common | |||
| Name | Powered Laser Surgical Instrument | Powered Laser Surgical Instrument | SAME |
Substantially Equivalent (SE) Comparison 8.
| Tab 1 General Comparison | |
|---|---|
| -------------------------- | -- |
6
| Indication for
use | The Diode Laser Hair Removal
System is intended for hair removal,
permanent hair reduction on all skin
types (Fitzpatrick skin type I-VI),
including tanned skin. 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 System is intended
for hair removal, permanent hair
reduction on all skin types
(Fitzpatrick skin type IVI),
including tanned skin.
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. | SAME |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Prescription
use or not | Prescription use | Prescription use | SAME |
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Laser Type | Diode laser | Diode Laser | SAME |
| Laser | |||
| Classification | Class IV | Class IV | SAME |
| Laser | |||
| Wavelength | 808nm | 808nm | SAME |
| Spot Size | 10mm x12mm | 1.44 cm2 | Different |
| Fluence | 5-120J/cm2 | 1-120J/ cm2 | Different |
| Frequency | 0.5-10Hz | 0.5-15Hz | Different |
| Pulse Duration | 10~300ms | 5-400ms | Different |
| Power Supply | 110-120 VAC, 15A Max. 60 Hz. | AC 110V/60Hz | Different |
Tab 2 Performance Comparison
7
| Dimension | 78(L)*65(W)*133(H)cm | 450mm× 550mm×380mm | Different |
|---|---|---|---|
| Weight | 54 kg | 52 Kg | Different |
Analysis:
Different - Spot size
The difference on Spot size would not impact the safety and effectiveness, because the final safety and effectiveness about clinical indications will depends on the amount of energy output per unit area, which would produce thermal effects to the patient's skin area irradiated to achieve claimed indication for use. And the proposed device has passed the IEC60601-1-2 test. IEC60601-1-2 test. IEC60601-2-22 test, IEC60825-1 test and performance test, the safety of the product can be ensured.
Different - Fluence
The proposed device has different Fluence from the predicate device.
For the difference on fluence between the predicate and proposed device(s), we can see that the proposed device has similar fluence with predicate device. The fluence between the proposed device and the predicate device only with minor difference. And we think this minor difference will not affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
Different - Frequency
The proposed device has different frequency from the predicate device.
The frequency of the proposed device is within the range of the predicate device, which can justify that the difference in the parameter of frequency will not raise new safety issues of the proposed device.
Different - Pulse Duration
The proposed device has different pulse duration from the predicate device.
For the difference on pulse duration between the predicate and proposed device(s), we can see that the pulse duration range of proposed device is within the range of the predicate device. The pulse duration between the proposed device and the predicate device only with minor difference. And we think this minor difference will not affect the effectiveness and safety. And the proposed device has passed the IEC60601-1 test, IEC60601-1-2 test, IEC60601-2-22 test, IEC60825-1 test and performance test, the safety and performance of the product can be ensured.
8
Different - Power Supply
The power supply for the proposed device is different from the predicate device. However, electrical safety and EMC test has been conducted on the proposed device and the test result show that the device can work normally under this power supply. Therefore, this difference will not affect safety and effectiveness of the proposed device.
Different - Dimension, Weight
The proposed device is different in dimension and weight from the predicate device. By complying with IEC 60601-1, the mechanical performance of the proposed device is determined to be accepted, therefore, this difference of dimension and weight have no effect the effectiveness and safety.
| ITEM | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Electrical | |||
| Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SAME |
| Laser Safety | Comply with IEC | ||
| 60601-2-22, IEC 60825-1 | Comply with IEC 60601-2-22, | ||
| IEC 60825-1 | SAME | ||
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | SAME |
| Irritation | No evidence of irritation | No evidence of irritation | SAME |
| Sensitization | No evidence of sensitization | No evidence of sensitization | SAME |
| Tab 3 Safety Comparison |
|---|
9. 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:
-
IEC 60601-1 Edition 3.2 2020-08, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2 Edition 4.1 2020-09, Medical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
-
IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification, and requirements
-
IEC 60601-2-22: 2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
A ISO 10993-10 Fourth edition 2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation
9
10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device Diode Laser Hair Removal System (K162659).