(86 days)
The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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 proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.
There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different.
The provided FDA 510(k) clearance letter and synopsis are for a Medical Diode Laser Hair Removal Device. This document is a regulatory submission for a physical medical device, not an AI/software as a medical device (SaMD). Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/SaMD (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not applicable to this device submission.
The document describes the device, its intended use, a comparison to a predicate device, and the non-clinical tests performed to demonstrate substantial equivalence for a hardware device. It explicitly states: "No clinical study is included in this submission."
Therefore, I cannot provide a table of AI acceptance criteria or details about AI-specific studies as requested, because this information is not present in the provided document and is not relevant to the type of device being cleared.
However, I can extract the acceptance criteria and performance information that is relevant to this type of physical device, based on the non-clinical testing mentioned:
Acceptance Criteria and Reported Device Performance (Non-Clinical for a Physical Device)
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1:2005+A1:2012+A2:2020 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance met. | "Complies with IEC 60601-1, IEC 60601-2-22" |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic - Requirements and tests met. | "Complies with IEC 60601-1-2" |
| Laser Safety | IEC 60601-2-22:2019, IEC 60825-1:2014 | Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment met; Equipment classification and requirements for laser safety met. | "Complies with IEC 60601-2-22, IEC 60825" |
| Biocompatibility | ISO 10993-5:2009 (Cytotoxicity) | No cytotoxic effects. | "No Cytotoxicity" |
| ISO 10993-10:2021 (Skin Sensitization) | No evidence of sensitization. | "No evidence of sensitization" | |
| ISO 10993-23:2021 (Irritation) | No evidence of irritation. | "No evidence of irritation" | |
| Performance Accuracy | N/A (General Performance Testing) | Spot size accuracy within specifications. | "Performance Testing for Spot Size Accuracy...met" |
| N/A (General Performance Testing) | Energy output accuracy within specifications. | "Performance Testing for...Energy Output Accuracy...met" | |
| Mechanical Performance | IEC 60601-1 (Implied) | Mechanical performance accepted despite dimension/weight differences. | "the mechanical performance of the proposed device is determined to be accepted" |
Regarding the AI/SaMD specific questions from your prompt:
- Sample size used for the test set and the data provenance: Not applicable. No AI/SaMD test set described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No AI/SaMD ground truth described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
FDA 510(k) Clearance Letter - Medical Diode Laser Hair Removal Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 25, 2025
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Xiaojie Shi
RA
Room 201, 2nd Floor, Building 2, No.52 Hongsong Road
High-tech Development Zone, 450001
China
Re: K251339
Trade/Device Name: Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
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: April 21, 2025
Received: April 30, 2025
Dear Xiaojie Shi:
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 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"
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K251339 - Xiaojie Shi
Page 2
(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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-reporting-mdr-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/medical-devices/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-devices/device-advice-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).
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K251339 - Xiaojie Shi
Page 3
Sincerely,
YAN FU -S Digitally signed by YAN FU -S
Date: 2025.07.25 12:10:49
-04'00'
for 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
Page 4
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251399
Device Name
Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Indications for Use (Describe)
The Medical Diode Laser Hair Removal Device (PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"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."
Page 5
510(k) Summary
The assigned 510(k) Number: K251399
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1. Date of preparation: 07/24/2025
2. Sponsor Identification:
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, P. R. China.
Contact Person: Xiaojie Shi
Position: RA
Tel: +86-18703657355
Fax: +86-0371-55677886
Email: shixiaojie1225@163.com
3. Designated Submission Correspondent
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Room 201, 2nd Floor, Building 2, No. 52 Hongsong Road, High-tech Development Zone, 450001, Zhengzhou City, Henan Province, P. R. China.
Contact Person: Xiaojie Shi
Tel: +86-18703657355
Fax: +86-0371-55677886
Email: shixiaojie1225@163.com
4. Identification of Proposed Device
Trade Name: Medical Diode Laser Hair Removal Device
Models: PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04
Page 6
Common Name: Powered Laser Surgical Instrument
Regulatory Information
Classification Name: Powered Laser Surgical Instrument
Classification: II
Product Code: GEX
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology.
Review Panel: General & Plastic Surgery
Intended Use:
The Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04) 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.
5. Device Description:
The proposed device, Medical Diode Laser Hair Removal Device (PZ-606VI、PZ-BDT68-01、PZ-BDT68-02、PZ-BDT68-03、PZ-BDT68-04), is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI);
The device incorporates a diode laser that emits invisible infrared laser radiation centered on a wavelength of 808 nm. According to the selective light absorption theory, the laser can be preferentially absorbed by the melanin in the hair follicle, thus achieving the purpose of permanent hair removal. 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. Hair growth must remain stable for a certain amount of time and must exceed the entire growth cycle of the hair follicle. Permanent hair removal does not mean that all hair in the treated area is completely lost. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin.
Page 7
There are 5 models included, PZ-606VI, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03 and PZ-BDT68-04, the five models have the same intended use, mechanism of action and principle, only the minimum values of energy density and pulse duration are different. The detailed difference shown as following:
Table 1 The difference of Models
| Model | Wavelength | Laser emitter | Pulse width (Pulse duration) (±10%) | Energy density (±20%) |
|---|---|---|---|---|
| PZ-606VI | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm² |
| 1000W Φ6mm treatment head | 4-44ms | (3-30) J/cm² | ||
| 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm² | |
| 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm² | ||
| 2000W Φ6mm treatment head | 3-22ms | (3-30) J/cm² | ||
| PZ-BDT68-01 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 6-108ms | (5-50) J/cm² |
| 1000W Φ6mm treatment head | 7-44ms | (5-30) J/cm² | ||
| 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 4-80ms | (5-95) J/cm² | |
| 2000W 12*24 laser treatment head | 8-80ms | (5-55) J/cm² | ||
| 2000W Φ6mm treatment head | 5-22ms | (5-30) J/cm² | ||
| PZ-BDT68-02 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 12-108ms | (10-50) J/cm² |
| 1000W Φ6mm treatment head | 15-44ms | (10-30) J/cm² | ||
| 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 9-80ms | (10-95) J/cm² | |
| 2000W 12*24 laser treatment head | 15-80ms | (10-55) J/cm² | ||
| 2000W Φ6mm treatment head | 8-22ms | (10-30) J/cm² | ||
| PZ-BDT68-03 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm² |
| 1000W Φ6mm treatment head | 7-44ms | (5-30) J/cm² |
Page 8
| Model | Wavelength | Laser emitter | Pulse width (Pulse duration) (±10%) | Energy density (±20%) |
|---|---|---|---|---|
| 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm² | |
| 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm² | ||
| 2000W Φ6mm treatment head | 5-22ms | (5-30) J/cm² | ||
| PZ-BDT68-04 | 808nm±10nm (Handle 1) | 1000W 12*12 laser treatment head | 3-108ms | (2-50) J/cm² |
| 1000W Φ6mm treatment head | 15-44ms | (10-30) J/cm² | ||
| 808nm±10nm (Handle 2) | 2000W 12*12 laser treatment head | 3-80ms | (3-95) J/cm² | |
| 2000W 12*24 laser treatment head | 3-80ms | (2-55) J/cm² | ||
| 2000W Φ6mm treatment head | 8-22ms | (10-30) J/cm² |
6. Identification of Predicate Device and reference devices
Predicate device:
510(k) Number: K161692
Product Name: Diode Laser Therapy Machine
Manufacturer: Beijing ADSS Development Co., Ltd
Reference device1:
510(k) Number: K140009
Product Name: The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [SopranoXL, SopranoXLi and SopranoICE]
Manufacturer: Alma Lasers Ltd
Reference device2:
510(k) Number: K210663
Product Name: Dermatological Diode Laser Systems
Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.
Reference device3:
510(k) Number: K141973
Product Name: Diode Laser Hair Removal System L808
Manufacturer: Beijing Anchorfree Technology Company Ltd.
7. 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:
Page 9
- IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
- IEC 60601-1-2:2014+A1:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic - Requirements and tests;
- IEC 60601-2-22:2019, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements
- ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5-Tests for in Vitro cytotoxicity.
- ISO 10993-10:2021, Biological Evaluation of Medical Devices, Part 10-Tests for skin sensitization
- ISO 10993-23:2021, Biological Evaluation of Medical Devices-Part 23: Tests for irritation.
- Performance Testing for Spot Size Accuracy and Energy Output Accuracy.
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Substantially Equivalent (SE) Comparison
Table 2 General Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | GEX | GEX | Same |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Intended Use | The Medical Diode Laser Hair Removal Device 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 Therapy Machine 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. | Same |
| Configuration | Main Unit | Main Unit | Same |
| Handle | Handpiece | Same | |
| Handle Button | Foot Control | Difference 1 |
Page 10
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Principle of Operation | Diode Laser | Diode Laser | Same |
| Laser Type | Diode Laser | Diode Laser | Same |
| Laser Classification | Class IV | Class IV | Same |
| Laser Wavelength | 808nm | 808nm | Same |
| Spot Size | 1.44cm² | 1.44cm² | Same |
| 2.88cm² | Difference 2 | ||
| 0.28cm² | |||
| Energy Density (Fluence) | (1)1000W 12*12 treatment head: (2-50) J/cm² | 2-120J/cm² | Difference 3 |
| (2)1000W Φ6mm treatment head: (3-30)J/cm² | |||
| (3)2000W 12*12 treatment head: (3-95)J/cm² | |||
| (4)2000W 12*24 treatment head: (2-55)J/cm² | |||
| (5)2000W Φ6mm treatment head: (3-30)J/cm² | |||
| Frequency | (1)1-10Hz | 1-10Hz | Same |
| (2)1-3Hz | |||
| Pulse Duration | (1)1000W 12*12 laser treatment head: 3-108ms | 9-143ms | Difference 4 |
| (2)1000W Φ6mm treatment head: 4-44ms | |||
| (3)2000W 12*12 laser treatment head: 3-80ms | |||
| (4)2000W 12*24 laser treatment head: 3-80ms | |||
| (5)2000W Φ6mm treatment head: 3-22ms | |||
| Power Supply | AC100-240V 50/60Hz | AC 110V/50Hz-60Hz | Difference 5 |
| Dimension | 550mm550mm1700mm | 5646112 cm | Difference 6 |
| 426354cm | |||
| 5646110cm | |||
| 5959146 cm | |||
| Weight | 68kg | 49kg | Difference 7 |
| 30kg | |||
| 45kg | |||
| 45kg |
Analysis:
Difference1:
Page 11
The predicate device emits laser through Foot Control; The proposed device emits laser through Handle Button. By complying with IEC 60601-1, the performance of the proposed device is determined to be accepted, therefore, this difference will not affect the effectiveness and safety.
Difference 2:
The spot size of the subject device (1.44cm², 2.88 cm², and 0.28 cm²) differs from predicate device (1.44cm²).
For the small spot size (0.28 cm²), which is the same as the spot size of the 6mm round tapered light guide tip in K140009, the round area is calculated to be 0.28 cm², it is the same as that of the subject device.
The large spot size (2.88 cm²) is similar to the spot size (3 cm²) of CM01D in K210663, and the spot size of the proposed device is slightly smaller than 3 cm².
So we think this minor difference between proposed device and predicate device 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.
Difference 3:
The proposed device has different Fluence from the predicate device. The fluence of the proposed device is within the range of the predicate device, which can justify that the difference in the parameter of fluence will not raise new safety issues of the proposed device. 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. And we think this minor difference will not affect the effectiveness and safety.
Difference 4:
The proposed device has different pulse duration from the predicate device (K161692). The pulse duration of the predicate device is 9-143ms, and the pulse duration of the subject device is 3-108ms. The pulse duration between the proposed device and the predicate device only with minor difference. The K141973 (pulse duration 2.9-348ms) as a scientifically valid justification that extending the pulse duration of the proposed device to 3-108ms is as safe and effective as the predicate device, and the K141973 has the same indication for use with predicate device 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.
Difference 5:
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.
Difference 6:
Page 12
The proposed device is different in dimension 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 have no effect the effectiveness and safety.
Difference 7:
The proposed device is different in 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 weight have no effect the effectiveness and safety.
Table 3 Safety Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Patient Contact Materials and Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No evidence of sensitization | No evidence of sensitization | Same |
| Irritation | No evidence of irritation | No evidence of irritation | Same |
| 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 | 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 | Comply with IEC 60601-2-22, IEC 60825 | Same |
10. 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.
§ 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.