(90 days)
Not Found
No
The summary describes a standard diode laser system with user-controlled settings and no mention of AI/ML capabilities or related performance metrics.
Yes
The device is clearly indicated for surgical applications involving soft tissues for various medical specialties, which inherently makes it a therapeutic device designed to treat or alleviate diseases and injuries. Additionally, the Summary of Performance Studies mentions IEC 60601-2-22, which covers "surgical, cosmetic, therapeutic and diagnostic laser equipment," and the predicate devices are described as "Diode Laser Therapy Device" and "Medical Diode Laser," further supporting its therapeutic classification.
No
The device is described as a surgical laser system used for incision, ablation, vaporization, and coagulation of soft tissues, not for diagnosis.
No
The device description explicitly details hardware components such as an optical block with laser diodes, mirrors, lenses, an aiming beam diode, an air cooling system, a laser power system, and an external footswitch. This indicates it is a physical medical device with integrated software for control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical applications involving the incision, ablation, vaporization, and coagulation of body soft tissues. This is a therapeutic and surgical function performed directly on the patient's body.
- Device Description: The description details a laser system designed to deliver laser beams for surgical procedures. It describes the physical components and how the laser is controlled for these surgical applications.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze these specimens.
Therefore, the Diode Laser System model Dawn-S is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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 980nm 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.
Product codes
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialist: 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
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)
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
Clinical Studies: No human clinical data is need for Diode Laser System model Dawn-S.
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
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"
1
(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).
2
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
3
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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4
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 and |
| in 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:
5
| Predicate
| Devices: | 510 (k) number: K212734 |
|---|---|
| Trade name: Diode Laser Therapy Device | |
| Product code: GEX | |
| 510(K) number:K240747 | |
| Device name: Medical Diode Laser | |
| Product code: GEX | |
| 510 (k) number: K240644 | |
| Device name: Medical Diode Laser | |
| Product 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:
6
| Item | Diode Laser System
model 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 for
Use | The Diode Laser System model
Dawn-S is indicated for incision,
excision, 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,
gynecology. The laser is further
indicated for laser assisted lipolysis.
The 1470 nm 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 | The Diode laser therapy
device is intended for delivery
of laser light to soft tissue in
the contact and non contact
mode during surgical
procedures. The device 's
980 nm laser is generally
indicated for use in incision,
excision, vaporization,
ablation, hemostasis or
coagulation of soft tissue in
ear, nose and throat and oral
surgery(otolaryngology),
dental procedures,
gastroenterology,
general surgery,
dermatology, plastic surgery,
podiatry, urology,
gynecology. The device is
further indicated for laser
assisted lipolysis.
The device's 1470nm laser
is intended for delivery of
laser light to soft tissue in
non-contact mode during
general surgery procedures,
indicated for the treatment of
reflux of the saphenous veins
associated with varicose
veins and varicosities. | The Medical Diode Laser
(Model: M2-GK) 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 Medical Diode
Laser (Model: M2-GK) is
further indicated for laser
assisted lipolysis. | The Medical Diode
Laser(Model: S1Pro) 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
Medical Diode Laser(Model:
S1 Pro) is further indicated
for laser assisted lipolysis. | Indications for
use of the
980nm diode
laser are the
same as the
indications of
the 980nm
laser in
K212734.
Indications for
use of the
1470nm diode
laser are
identical to the
indications for
use of the
1470nm laser
in K240747
and K240644. |
| | coagulation and endovenous
occlusion of the greater saphenous
vein in patients with superficial vein
reflux. The laser is further indicated
for 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-980nm
15W-1470nm | 12W-1470nm | 980nm power
is similar to
K212734, only
1W lower.
1470nm power
is identical to
K240747 and
slightly higher
than K240644 |
| Aiming Beam | 650nm,