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.

Device Description

The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types. There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device are Handpiece, Touch screen, Emergency stop switch, Key switch, LED screen, and Foot switch.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Diode Laser Hair Removal System). It describes the device, its intended use, and compares it to a legally marketed predicate device to demonstrate substantial equivalence.

However, the document does not contain information regarding detailed acceptance criteria for device performance, nor does it present the results of a study designed to prove the device meets specific acceptance criteria in terms of efficacy or performance on hair removal.

Here’s a breakdown of why the requested information cannot be fully provided from the given text:

Table of acceptance criteria and reported device performance: The document lists technical specifications for the proposed device and compares them to the predicate device (e.g., laser type, wavelength, spot size, fluence, frequency). However, it does not define specific acceptance criteria related to efficacy (e.g., "X% hair reduction in Y% of patients") nor does it present study data against such acceptance criteria. The "Remarks" column in Table 4 simply states "SE" (Substantially Equivalent) or "Discussion 1" if there's a difference in a parameter. "Discussion 1" clarifies that the proposed device's fluence range is within the predicate's, which doesn't equate to performance acceptance criteria.
Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study data is presented. The document explicitly states: "No clinical study is included in this submission."
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical performance study requiring ground truth establishment is presented.
Adjudication method for the test set: Not applicable, as no clinical performance study requiring adjudication is presented.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. The device is a laser hair removal system, not a diagnostic device requiring human reader interpretation or AI assistance in the same way.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable, as no clinical performance study requiring ground truth is presented.
The sample size for the training set: Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.
How the ground truth for the training set was established: Not applicable, as this device does not involve machine learning or AI algorithms.

Summary of what the document does provide regarding acceptance and testing:

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for approval. This typically involves showing that the new device has the same intended use, technological characteristics, and safety profile as a legally marketed device.

The non-clinical testing detailed in section 7 confirms that the device complies with relevant safety and electrical standards:

IEC 60601-1: General Requirements For Basic Safety And Essential Performance
IEC 60601-2-22: 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
IEC 60601-1-2: Electromagnetic compatibility
ISO 10993-5: Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
ISO 10993-10: Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity
AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

The "acceptance criteria" here are implicitly the adherence to these standards and the demonstration of equivalent technical specifications (Table 4) and safety characteristics (Table 5) to the predicate device. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests that confirmed compliance with these standards and the comparison tables showing technical equivalence.

The document explicitly states "No clinical study is included in this submission." This means that the 510(k) clearance was based on demonstrating equivalence, not on providing new clinical performance data to meet specific efficacy acceptance criteria.

In conclusion, the document's purpose is to establish substantial equivalence based on technical specifications and safety standards, rather than proving performance against specific efficacy acceptance criteria via clinical trials.

Summary

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April 6, 2020

Beijing Sano Laser S&T Development Co., Ltd % Huifang Zhao Consultant Microkn Business Consulting (Shanghai)Co., Ltd Room 1319, Block A, No 3699, Gonghexin Road, Jingan District Shanghai, 200435 CN

Re: K191970

Trade/Device Name: Diode Laser Hair Removal System 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: March 5, 2020 Received: March 5, 2020

Dear Huifang Zhao:

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.

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

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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 medical devices and radiation-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,

Jessica Mavadia-Shukla, Ph.D. 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

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Indications for Use

510(k) Number (if known) K191970

Device Name Diode Laser Hair Removal System

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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510(k) Summary

Date Prepared: 4/5/2020

1. Contact Information

1.1. Applicant

Applicant Name:	Beijing Sano Laser S&T Development Co., Ltd.
Address:	Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi District, Beijing, China
Contact Person:	Hongbo Zhang
Title:	Manager
Telephone:	+86 10 57150601
E-mail:	360349720@qq.com

1.2. Consultant

Company:	Microkn Business Consulting (Shanghai) Co., Ltd.
Address:	Room 1319, Block A, No 3699, Gonghexin Road, JinganDistrict, Shanghai, China
Contact Person:	Huifang Zhao
Telephone:	+86 13961151430
Email:	huifang.zhao@microkn.com

2. Device information

Trade Name:	Diode Laser Hair Removal System
Common Name:	Powered Laser Surgical Instrument
Model(s):	P-808, P-808L, P-808S, P-808W
Classification:	II
Product Code:	GEX
Regulation:	21 CFR 878.4810

3. Legally Marketed Primary Predicate Device

Product name:	Diode Laser Therapy Machine
510(k) Number:	K161692
Product Code:	GEX
Manufacture:	Beijing ADSS Development Co., Ltd

4. Device Description

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The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended for hair removal, permanent hair reduction on all Fitzpatrick skin types.

There are 4 models included, P-808, P-808L, P-808S and P-808W, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown in Table 1.

Model	P-808	P-808L	P-808S	P-808W
Size (cm)	46x36x105	45x37x110	47x36x113	47x32x112
Size of LED screen (inch)	10	10	12	10

Table 1 the Difference of Models

The main components of proposed device are shown in Table 2.

Table 2 Main Components of Proposed Device

Components	Function Description	Applied Model(s)
Handpiece	Deliver the laser to area to be treated	All Models
Touch screen	The user interface and for controlling of the system	All Models
Emergency stop switch	Stop the system in case of emergency situation	All Models
Key switch	Start the system	All Models
LED screen	Display the working status of the system, set the treatment parameters	All Models
Foot switch	control the laser output	All Models

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5. 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.

6. Substantially Equivalent (SE) Comparison

The Diode Laser Hair Removal System has been carefully compared to legally marketed devices with respect to intended use, configuration, principle of operation (Table 3), and performance specifications (Table 4).

Item	Proposed Device	Predicate Device	Remark
Product Code	GEX	GEX	SE
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810	SE
Intended Use	The Diode Laser HairRemoval System isintended for hairremoval, permanent hairreduction on all skintypes (Fitzpatrick skintype I-VI), includingtanned skin. Permanenthair reduction is definedas the long-term, stablereduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after thecompletion of atreatment regime.	The Diode Laser TherapyMachine is intended for hairremoval, permanent hairreduction on all skin types(Fitzpatrick skin type I-VI),including tanned skin.Permanent hair reduction isdefined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime.	SE, withdifference inwording,while theactualindicationsare thesame.

Table 3 General Comparison

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Configuration
	Main Unit	Main Unit	SE
	Handpiece	Handpiece	SE
	Foot Control	Foot Control	SE
PrincipleofOperation	Diode Laser	Diode Laser	SE

Table 4 Performance Comparison

ltem	Proposed Device	Predicate Device	Remark
Laser Type	Diode Laser	Diode Laser	SE
Laser Classification	Class IV	Class IV	SE
Laser Wavelength	808 nm	808 nm	SE
Spot Size	1.44 cm²	1.44 cm²	SE
Fluence	10-120 J/cm2	2-120 J/cm2	Discussion 1
Frequency	0.5-10 Hz	1-10 Hz	SE
Power Supply AC	110V/60Hz	110 V/50 Hz-60 Hz	SE

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Discussion 1

The proposed device is different from the predicate device in fluence value, but the proposed device's fluence value range is included in the predicate's fluence value. Therefore, this difference will not affect the substantially equivalency.

Safety comparison has been done to validate the EMC, biocompatibility specification and safety of the device (Table 5).

Item	Proposed Device	Predicate Device	Remark
Patient Contact Materials and Biocompatibility
Patient ContactMaterials	Sapphire in handpiece andhandpiece tip (Stainless Steel)	Sapphire in handpiece andhandpiece tip (Stainless Steel)	SE
Cytotoxicity	No Cytotoxicity	No Cytotoxicity	SE
Skinsensitization	No evidence of sensitization	No evidence of sensitization	SE
Irritation	No evidence of irritation	No evidence of irritation	SE
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 5 Safety Comparison

7. Non-Clinical Testing

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 60601-1:2012 Medical Electrical Equipment Part 1: General . Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22:2012, Medical Electrical Equipment Part 2-22: Particular .

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Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;

IEC 60825-1: 2007, Safety of laser products Part 1: Equipment classification . and requirements;
IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General . requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests;
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for . Vitro cytotoxicity;
ISO 10993-10:2010, Biological Evaluation of Medical Device, Part 10-Test for . irritation and delay-type hypersensitivity AMENDMENT 1: Performance Testing for Spot Size Accuracy and Energy Output Accuracy.

8. Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

§ 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.