(90 days)
The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.
The 980mm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.
The 1470mm diode laser is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.
The Diode Laser System model Dawn-S is intended for delivery of dual wavelength laser beam to soft tissue. The Diode Laser System model Dawn-S generates a 1470nm wavelength laser and 980nm wavelength laser.
The laser is controlled via a high-resolution color touch screen display includes a user interface allowing selection of CW and Pulse mode as well as duty cycle and frequency of operation, laser power level and Stand-by/Ready selection.
The laser system consists of an optical block with contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and the laser power system, as well as an external footswitch for laser activation.
This FDA 510(k) summary provides information on the Diode Laser System model Dawn-S. The information focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study establishing new acceptance criteria or specific performance metrics with detailed statistical analysis.
Based on the provided document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance endpoints (e.g., accuracy, sensitivity, specificity) with numerical targets. Instead, it relies on comparison to predicate devices and compliance with recognized standards.
| Acceptance Criteria (Inferred from regulatory standards and predicate comparison) | Reported Device Performance |
|---|---|
| General Safety and Essential Performance: Adherence to recognized medical electrical equipment standards. | Compliance with IEC 60601-1:2005+AMD1:2012+AMD2:2020 |
| Electromagnetic Compatibility: Adherence to EMC standards. | Compliance with IEC 60601-1-2:2014+A1:2020 |
| Laser Safety: Adherence to laser product safety standards. | Compliance with IEC 60825-1:2014 |
| Surgical Laser Specific Safety and Performance: Adherence to standards for surgical laser equipment. | Compliance with IEC 60601-2-22:2019 |
| Indications for Use: Comparable to predicate devices. | The indications for use of Diode Laser System model Dawn-S are stated to be the same as those of the predicate devices. This implicitly means the device performs adequately for incision, ablation, vaporization, and coagulation of body soft tissues in various surgical applications, as well as laser-assisted lipolysis and endovenous occlusion of the greater saphenous vein, similar to the predicate devices. |
| Technological Characteristics: Similar to predicate devices. | Wavelength (980nm, 1470nm) is identical to predicate K212734 and K240747. Output Power: 15W (980nm) is similar to K212734 (16W), 15W (1470nm) is identical to K240747 and slightly higher than K240644 (12W). Aiming Beam, Operation Mode, Pulse Duration, Power Supply, User Interface, Laser Beam Delivery, and Cooling System are all stated as identical or similar to predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No human clinical data is need for Diode Laser System model Dawn-S". Therefore, there was no "test set" of patient data for a clinical study as would be understood for an AI/diagnostic device.
The "test set" for this device appears to be the physical device itself undergoing non-clinical (bench) testing to demonstrate compliance with various IEC standards. No information is provided regarding the specific number of units tested, the origin of these units, or if any particular "data provenance" (e.g., country of origin) applies to non-clinical bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As no human clinical data was used and the device's performance was evaluated through non-clinical testing against recognized standards, there was no "ground truth" to be established by experts in the context of evaluating diagnostic accuracy or clinical outcomes. The "ground truth" here is the adherence to engineering and safety standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert adjudication of results. The non-clinical testing involved engineers and technicians performing standardized tests.
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
Not applicable. This is a laser surgical instrument, not a diagnostic AI device requiring human reader interpretation, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware medical device (laser system), not an AI algorithm. Its performance is inherent in its operation, not derived from an algorithm producing an output for a human to interpret.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for demonstrating its safety and effectiveness is primarily established by:
- Compliance with Recognized Standards: The primary "ground truth" is that the device meets the specifications and safety requirements outlined in the cited IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 60601-2-22).
- Substantial Equivalence to Predicate Devices: The comparison to legally marketed predicate devices (K212734, K240747, K240644) serves as a form of "ground truth" by demonstrating that the new device shares fundamental technological characteristics and indications for use with devices already deemed safe and effective.
No pathology, expert consensus on images, or patient outcome data from a clinical trial were used to establish ground truth for this 510(k) submission.
8. The Sample Size for the Training Set
Not applicable. This is a hardware medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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December 26, 2024
Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd Lily Zhou Management Representative 2F, Building 11, Lane 1175, Tongpu Rd, Shanghai, 200333 China
Re: K243037
Trade/Device Name: Diode Laser System model Dawn-S 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: July 22, 2024 Received: September 27, 2024
Dear Lily Zhou:
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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(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 OS 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.
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 Rue"). 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-advicecomprehensive-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-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). 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).
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Sincerely,
Digitally signed by Shlomit Shlomit Halachmi -S Date: 2024.12.26 17:23:42 Halachmi -S -05'00'
Shlomit Halachmi 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
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Indications for Use
510(k) Number (if known) K243037
Device Name Diode Laser System model Dawn-S
Indications for Use (Describe)
The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.
The 980mm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis.
The 1470mm diode laser is indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.
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 K243037
Date Prepared: December 26, 2024
This summary of 510 (k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 801.92
1. Submitter's Information
| Name of Sponsor: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| Address: | 2F, Building 11, Lane 1175, Tongpu Rd.,Shanghai 200333, China |
| Contact Name: | Lily Zhou |
| Telephone No.: | 0086-021-62642623 |
| Fax No.: | 0086-021-52827988 |
| Email Address: | regulatory@wonderful-sh.com |
Correspondent's Information
| Company Name: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| --------------- | --------------------------------------------------- |
| Company Name: | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
|---|---|
| Correspondent Name: | Lily Zhou |
| Telephone No.: | 0086-021-62642623 |
| Email Address: | regulatory@wonderful-sh.com |
3. Trade Name, Common Name, Classification
| Trade Name: | Diode Laser System |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Model: | Dawn-S |
| Regulation Name: | Laser surgical instrument for use in general and plastic surgery andin dermatology |
| Product Code: | GEX |
| Classification Panel: | General and Plastic Surgery |
| Device Class: | II |
| Classification Regulation: | 21 CFR 878.4810 |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
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| PredicateDevices: | 510 (k) number: K212734 |
|---|---|
| Trade name: Diode Laser Therapy DeviceProduct code: GEX | |
| 510(K) number:K240747Device name: Medical Diode LaserProduct code: GEX | |
| 510 (k) number: K240644Device name: Medical Diode LaserProduct code: GEX |
5. Description of the Device
The Diode Laser System model Dawn-S is intended for delivery of dual wavelength laser beam to soft tissue. The Diode Laser System model Dawn-S generates a 1470nm wavelength laser and 980nm wavelength laser.
The laser is controlled via a high-resolution color touch screen display includes a user interface allowing selection of CW and Pulse mode as well as duty cycle and frequency of operation, laser power level and Stand-by/Ready selection.
The laser system consists of an optical block with contains the laser diode, mirrors, lens, and aiming beam diode, an air cooling system, and the laser power system, as well as an external footswitch for laser activation.
6. Intended Use/Indication for Use
The Diode Laser System model Dawn-S is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in surgical application.
The 980 nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngology), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology, The laser is further indicated for laser assisted lipolysis.
The 1470nm diode laser is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ ENT and Radiology, Oral Surgery and Dental procedures, Endovascular, coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The laser is further indicated for laser assisted lipolysis.
7. Technological Characteristics
The Diode Laser System model Dawn-S uses the same technology that is utilized in the predicate device. A comparison of technological characteristics is provided in the following table:
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| Item | Diode Laser Systemmodel Dawn-S | Predicate Device | Comparison | ||
|---|---|---|---|---|---|
| General Information | |||||
| Product Code | GEX | GEX | GEX | GEX | Identical |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Class | II | II | II | II | Identical |
| Product Name | Diode Laser System model Dawn-S | Diode laser therapy device | Medical Diode Laser | Medical Diode Laser | |
| 510 (K) No. | K243037 | K212734 | K240747 | K240644 | |
| Models | Dawn-S | ST-AR | M2-GK | S1Pro | |
| Indications forUse | The Diode Laser System modelDawn-S is indicated for incision,excision, ablation, vaporization, andcoagulation of body soft tissues insurgical application.The 980 nm diode laser is generallyindicated for use in surgicalapplications requiring thevaporization, incision, excision,ablation, cutting and hemostasis, orcoagulation of soft tissue, including:general surgery, ENT (ear, nose,and throat) and oral surgery(otolaryngology), dental procedures,dermatology, plastic surgery,podiatry, urology, gastroenterology,gynecology. The laser is furtherindicated for laser assisted lipolysis.The 1470 nm diode laser is indicatedfor use in surgical applicationsrequiring the vaporization, incision,excision, ablation, cutting andhemostasis, or coagulation of softtissue in conjunction withendoscopic equipment for medicalspecialist including: Urology,Thoracic Surgery, Plastic Surgeryand Dermatology, General Surgery,Ophthalmology, Orthopedics,Podiatry, Arthroscopy, SpinalSurgery, Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology, Head/neck/ENTand Radiology, Oral Surgery andDental procedures | The Diode laser therapydevice is intended for deliveryof laser light to soft tissue inthe contact and non contactmode during surgicalprocedures. The device 's980 nm laser is generallyindicated for use in incision,excision, vaporization,ablation, hemostasis orcoagulation of soft tissue inear, nose and throat and oralsurgery(otolaryngology),dental procedures,gastroenterology,general surgery,dermatology, plastic surgery,podiatry, urology,gynecology. The device isfurther indicated for laserassisted lipolysis.The device's 1470nm laseris intended for delivery oflaser light to soft tissue innon-contact mode duringgeneral surgery procedures,indicated for the treatment ofreflux of the saphenous veinsassociated with varicoseveins and varicosities. | The Medical Diode Laser(Model: M2-GK) is indicatedfor use in surgicalapplications requiring thevaporization, incision,excision, ablation, cutting andhemostasis, or coagulation ofsoft tissue in conjunction withendoscopic equipment formedical specialist including:Urology, Thoracic Surgery,Plastic Surgery andDermatology, GeneralSurgery, Ophthalmology,Orthopedics, Podiatry,Arthroscopy, Spinal Surgery,Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology,Head/neck/ENT andRadiology, Oral Surgery andDental procedures,Endovascular coagulationand endovenous occlusion ofthe greater saphenous vein inpatients with superficial veinreflux. The Medical DiodeLaser (Model: M2-GK) isfurther indicated for laserassisted lipolysis. | The Medical DiodeLaser(Model: S1Pro) isindicated for use in surgicalapplications requiring thevaporization, incision,excision, ablation, cuttingand hemostasis, orcoagulation of soft tissue inconjunction with endoscopicequipment for medicalspecialist including: Urology,Thoracic Surgery, PlasticSurgery and Dermatology,General Surgery,Ophthalmology,Orthopedics, Podiatry,Arthroscopy, Spinal Surgery,Gynecology, PulmonarySurgery, Neurosurgery,Gastroenterology,Head/neck/ENT andRadiology, Oral Surgery andDental procedures,Endovascular coagulationand endovenous occlusionof the greater saphenousvein in patients withsuperficial vein reflux. TheMedical Diode Laser(Model:S1 Pro) is further indicatedfor laser assisted lipolysis. | Indications foruse of the980nm diodelaser are thesame as theindications ofthe 980nmlaser inK212734.Indications foruse of the1470nm diodelaser areidentical to theindications foruse of the1470nm laserin K240747and K240644. |
| coagulation and endovenousocclusion of the greater saphenousvein in patients with superficial veinreflux. The laser is further indicatedfor laser assisted lipolysis. | |||||
| Performance Information | |||||
| Wavelength | 980nm, 1470nm | 980nm, 1470nm | 980nm, 1470nm | 1470nm | Identical |
| Output Power | 15W (980nm)15W (1470nm) | 16W/980nm±20%,4.5W/1470nm±20% | 30W-980nm15W-1470nm | 12W-1470nm | 980nm poweris similar toK212734, only1W lower.1470nm poweris identical toK240747 andslightly higherthan K240644 |
| Aiming Beam | 650nm, <5mW, adjustable | 650 nm, red 0.5 mW, usercontrolled intensity | Red 650nm (<2mW) | Diode laser of 650 nm, power<2mW,adjustablebrightness. | Samewavelength,red light, theaiming beamof subjectedand predicateddevices are allclassified asthe lowestsafety level,Class I. |
| Operation Mode | Continuous or Pulsed | Continuous or Pulsed | CW, Pulsed, Single Pulse | Continuous, single wave, pulsed | Identical |
| Pulse Duration | 10-990ms | 980nm 1% ~ 100%,1470nm 2% ~100%,continuously adjustableenergy | 10ms-1s | 10-990ms | IdenticaltoK240644 |
| Power Supply | 100-240V, 50-60Hz | AC110V±11V, 60HZ | 100-240V, 47-63 Hz | 100-240VAC, 50-60Hz | Identical |
| User Interface | 8" Color touch screen | Color touch screen | Color touch screen | Color touch screen | Identical |
| Laser BeamDelivery | Fiber | Sterile fiber, for single use | Fiber | Bare Fiber | Identical |
| Cooling System | Air cooled | Air cooled | Air cooled | Air cooled | Identical |
| Safety Information | |||||
| Non-clinicalSafety testing | IEC 60601-1:2005+AMD1:2012+AMD2:2020 ;IEC 60601-1-2 :2014+A1: 2020 ;IEC 60825-1:2014;IEC 60601-2-22: 2019 | Comply with IEC60601-1:2005+A1:2012, IEC60825-1:2014,IEC 60601-2-22:2007+A1:2012; IEC | IEC 60601-2-22:2007, IEC60601-1:2005 (ThirdEdition);IEC 60825-1:2007; EN | IEC 60601-1:1988+Al:1991+A2:1995:IEC60601-1-2IEC 60601-2-22:1995 | Same standardas predicatedevices, butcomply with |
| 60601-1-2:2014 | 60601-1-2:2007 | IEC 60825-1:2007 | the latestversion | ||
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K243037
8. Discussion of Non-clinical Testing
To verify the performance requirements of Diode Laser System model Dawn-S, the following tests were performed. It shows that the testing results do support substantial equivalence.
IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
IEC 60601-2-22 Edition 3.1 2012-10 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
9. Brief discussion of clinical tests
No human clinical data is need for Diode Laser System model Dawn-S
10. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shanghai Wonderful Opto-Electrics Tech Co., Ltd. concludes that:
- The indications for use of Diode Laser System model Dawn-S are the same as those of the ● predicate devices.
- The technological characteristics are the same or similar to those of the predicate devices.
- Demonstrated by the safety and performance tests, Diode Laser System model Dawn-S is substantially equivalent to the predicate devices.
§ 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.