(150 days)
No
The description focuses on the laser technology and embedded processor for control, with no mention of AI, ML, or related concepts like image processing or training/test data.
Yes
The device is described as "intended for coagulation, vaporization, ablation or cutting of soft tissue (skin)" and specifically mentions that it undergoes testing for "surgical, cosmetic, therapeutic and diagnostic laser equipment," indicating its use in treating medical conditions.
No
Explanation: The "Intended Use / Indications for Use" section states the device is intended for "coagulation, vaporization, ablation or cutting of soft tissue (skin)", which are all therapeutic actions, not diagnostic ones. While one of the standards mentioned in "Summary of Performance Studies" is for "surgical, cosmetic, therapeutic and diagnostic laser equipment," the explicit intended use of this specific device focuses on treatment, not diagnosis.
No
The device description explicitly lists hardware components such as the main body, color touch screen, articulated arm, hand piece, and foot switch, and the performance studies focus on hardware safety and performance standards for laser systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation, vaporization, ablation or cutting of soft tissue (skin)". These are procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers thermal energy to the skin. This is a therapeutic or surgical device, not one used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue on the patient.
N/A
Intended Use / Indications for Use
The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
Product codes
GEX
Device Description
Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin), skin around the eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: Testing conducted on the LOTUS III Multi-Pulsed Er:YAG Laser System shows that it refers to the relevant mandatory performance standards for laser products 21 CFR 1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards:
- -LOTUS III Laser System is tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -LOTUS III laser system is tested and evaluated according to FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability.
- LOTUS III Laser System is tested and evaluated according to FDA-recognized consensus standard IEC 60601-2-22: 2007 (Third Edition) + A1:2012. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- -Safety of laser products is evaluated according to FDA-recognized consensus standard IEC 60825-1: 2007. All the results presented here demonstrated the equipment classification and requirements.
- -Risk management was recorded according to the FDA-recognized consensus standard ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- -Usability was documented according to the FDA-recognized consensus standard IEC 62366: 2008. All the results presented here demonstrated the application of usability engineering to medical devices.
- Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Laseroptek Co., Ltd. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K182045
Trade/Device Name: Lotus III Multi-Pulsed Er: YAG Laser 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: December 6, 2018 Received: December 7, 2018
Dear Mark Job:
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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Binita S. Ashar. M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) N/A
Device Name
LOTUS III Multi-Pulsed Er:YAG Laser System
Indications for Use (Describe)
The LOTUS III Multi-Pulsed Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery, and ophthalmology (skin around the eyes).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
5. 510(k) Summary
1. General Information
| Applicant/Submitter: | Laseroptek Co., Ltd. |
|---|---|
| Address: | #116, #117, #203, #204 Hyundai I Valley 31 |
| Galmachi-Ro, Jungwon-Gu | |
| Seongnam-Si, Gyeonggido, 13212 | |
| Rep. of Korea (South Korea) | |
| Tel) +82.31.8023.5150 | |
| Fax) +82.31.8023.5151 | |
| Contact Person: | Mina Joo, BT Solutions, Inc. |
| Address: | Unit 402, 91-14 Seolleung-ro, Gangnam-gu, Seoul, |
| Republic of Korea | |
| Tel) +82.2.538.9140 | |
| Email) smanager@btsolutions.co.kr | |
| Preparation Date: | December-17-2018 |
2. Device Name and Code
| Device Trade Name: | LOTUS III Multi-Pulsed Er:YAG Laser System |
|---|---|
| Common Name: | Er:YAG Pulsed Surgical Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Product Code: | GEX |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery (ODE) |
3. Technical Characteristics in Comparison to Predicate Device and Reference predicate Devices
LOTUS III Multi-Pulsed Er: Y AG Laser System is substantially equivalent to the following legally marketed predicate device and Reference devices
| 510(K) Number | Primary
Predicate Device | Predicate Device | Predicate Device | Proposed Device |
|---------------|-----------------------------|------------------|------------------|-----------------|
| K083253 | K093162 | K143723 | K182045 | |
4
| Manufacturer | Laseroptek Co.,
Ltd. | Stegne 7 | Stegne 7 | Laseroptek Co.,
Ltd. |
|---------------------------------|-------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Device Name | LOTUS II Pulsed
Er:YAG Laser
System | Fotona Fidelis
III
Er:YAG/Nd:YAG Laser System
Family | Fotona Dynamis
Pro Family | LOTUS III Multi-
Pulsed Er:YAG
Laser System |
| Clearance Date: | 15 May 2009 | 22 Jan 2010 | 9 April, 2015 | Not available |
| Classification /
Regulation | Class 2/ 21 CFR
878.4810 | Class 2/ 21 CFR
878.4810 | Class 2/ 21 CFR
878.4810 | Class 2/ 21 CFR
878.4810 |
| Product Code | GEX | GEX | GEX, ONG | GEX |
| Laser Type | Er:YAG | Er:YAG | Er:YAG | Er:YAG |
| Output mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Wavelength | 2940 nm | 2940 nm | 2940 nm | 2940 nm |
| Pulse
Characteristics: | | | | |
| Pulse Duration
(Pulse Width) | Short: 350 µs
Long: 1 ms | 50 – 1000 µs | MSP: 100 us
SP: 300 us
LP: 600 us
VLP: 1000 us
XLP: 1500 us
SMOOTH mode:
250 ms
V-SMOOTH
mode with L-
Runner; 100 ms,
200 ms, 300 ms,
400 ms and 500
ms
TURBO | 40 µs
200 µs
600 µs
1 ms
5 ms
Six pulse mode,
SM (200µs x 6
shots) |
| Pulse Energy
(max) | Short: 1500 mJ
Long: 1000 mJ | 20 – 1500 mJ | 30-3000 mJ | 40 µs: 600 mJ
200 µs: 3000 mJ
600 µs: 900 mJ
1 ms: 1000 mJ
5 ms: 900 mJ
SM: 18000 mJ |
| Average Power
(max) | 15 W | up to 20 W | up to 20 W | Up to 30 W |
| Spot size (mm) | Zoom: 17mm | - | Zoom: 17mm | Black: 1~7mm
Blue: 15mm |
| Repetition Rate
(Hz) | Up to 10 Hz | Up to 50 Hz | Up to 50 Hz | Up to 40 Hz |
| Fluence max | 191 J/cm² (spot 1
mm) | - | 382 J/cm² (spot 1
mm) | 382 J/cm² (spot 1
mm)
SM: 2292 J/cm²
(spot 1 mm) |
510(k) Summary
5
| Aiming beam | Laser diode, 635
nm | Laser diode, 650
nm | Laser diode, 650
nm | Laser diode, 635
nm |
|--------------------------------------------|--------------------------------------------|-----------------------------------|--------------------------------------------|--------------------------------------------|
| Physical
Characteristics: | | | | |
| Beam Delivery
System | Articulated Arm
with Handpiece | Articulated Arm
with Handpiece | Articulated Arm
with Handpiece | Articulated Arm
with Handpiece |
| Interface | LCD
Touchscreen | LCD
Touchscreen | LCD
Touchscreen | LCD
Touchscreen |
| Activation | Via foot-switch | Via foot-switch | Via foot-switch | Via foot-switch |
| Cooling System | Internal Water to
Air Heat
Exchanger | - | Internal Water to
Air Heat
Exchanger | Internal Water to
Air Heat
Exchanger |
| System
Dimensions
(mm) | 330(W) x
941.5mm(D) x
905.9mm(H) | - | - | 298(W) x 819(L)
x 936(H) |
| System Weight
(kg) | 100 kg | - | - | 80 kg |
| Electrical
Requirements | AC 220 V, 50/60
Hz | - | - | AC 220-230 V,
50/60 Hz |
510(k) Summary
Reference Devices:
.
Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV Laser System (K172639) *
*This reference device is referred, of which cleaning method is the same to those of the PALLAS 308/311 Solid-State UV Laser System.
4. Device Description
Laseroptek Co. Ltd.'s LOTUS III Pulsed Er:YAG Laser System is an Erbrium:YAG laser with a wavelength of 2940 nm. A set of Er: YAG lasers is controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.
5. Indications / Intended Use
The LOTUS III Multi-Pulsed Er:YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).
6. Performance Data
Non-clinical tests: Testing conducted on the LOTUS III Multi-Pulsed Er:YAG Laser System shows that it refers to the relevant mandatory performance standards for laser products 21 CFR
6
510(k) Summary
1040.10 and 1040.11. Other performance, such as electromagnetic compliance, etc, were tested using following standards:
- -LOTUS III Laser System is tested and evaluated according to AAMI/ANSI ES60601-1:2005 and A1:2012. All the results presented in the submission demonstrate general requirements for basic safety and essential performance.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2: 2007. All the results presented here demonstrated the requirements and tests for electromagnetic disturbances.
- -LOTUS III laser system is tested and evaluated according to FDA-recognized consensus standard IEC 60601-1-6:2010/AMD1:2013. All the results presented here demonstrated the General requirements for safety - Collateral Standard: Usability.
- LOTUS III Laser System is tested and evaluated according to FDA-recognized consensus standard IEC 60601-2-22: 2007 (Third Edition) + A1:2012. All the results presented here demonstrated the particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- -Safety of laser products is evaluated according to FDA-recognized consensus standard IEC 60825-1: 2007. All the results presented here demonstrated the equipment classification and requirements.
- -Risk management was recorded according to the FDA-recognized consensus standard ISO 14971: 2012. All the results presented here demonstrated the application of risk management to medical devices.
- -Usability was documented according to the FDA-recognized consensus standard IEC 62366: 2008. All the results presented here demonstrated the application of usability engineering to medical devices.
- Biocompatibility was tested and evaluated according to FDA-recognized consensus standard ISO 10993-5: 2009 and ISO 10993-10: 2010.
7. Substantial Equivalence
LOTUS III Multi-Pulsed Er: Y AG Laser System, from both a design and clinical perspective, uses similar or identical technology as the cited predicate devices and has the same intended uses. I The general features of LOTUS III are similar to those of the predicates in particular as regards the classification IV laser, the equipment of the cooling system and the electrical specifications. Also, the predicate devices are equipped with a touch screen and activate via foot-switch.
Based upon the predicted overall performance characteristics for the LOTUS III Multi-Pulsed Er:YAG Laser System, Laseroptek Co. Ltd. believes that no significant differences exist in usage of its underlying technological principles between LOTUS III Multi-Pulsed Er: Y AG Laser System and the cited predicate devices.
8. Conclusions
On the basis of the information provided in this Summary, Laseroptek Co., Ltd. Believes that LOTUS III Multi-Pulsed Er:YAG Laser System is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.