(192 days)
The Lotus II Pulsed Er:YAG Laser System is a pulsed erbium doped yttrium-aluminum-garnet (Er:YAG) laser. It outputs laser light with a wavelength of 2940 nm, a wavelength very efficiently absorbed by the skin. It is intended for coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). This includes skin resurfacing and the treatment of wrinkles
The Lotus II 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).
The Lotus II laser system is an Erbium:YAG laser with a wavelength of 2.94 um. Laser activation is by footswitch. Three basic elements of operations are as follows:
- A Er:YAG crystal is used as a gain medium which produces a laser beam.
- A resonator then amplifies the beam.
- A lamp that contains Xe gas is used, as a pumping light source. The lamp requires a high-pressure power source device for operation. When the electric energy generated from the high-pressure power source is induced into the electrode of the lamp, it converts into light energy. This converted light energy pumps the Er:YAG crystal – a gain medium – and the light exhausted from the crystal is amplified into a specific wavelength light. As it passes between the resonant gases, laser beam radiates to an output unit.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Lotus II Pulsed Er:YAG Laser System:
Acceptance Criteria and Device Performance Study for Lotus II Pulsed Er:YAG Laser System (K083253)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated by substantial equivalence to predicate devices (DermaStar Er:YAG Laser System (K014057) and MCL 30 Dermablate Er:YAG Laser System (K042968)). |
| Intended Use | Same or very similar to predicate devices: coagulation, vaporization, ablation and/or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and ophthalmology (skin around the eyes). Includes skin resurfacing and treatment of wrinkles. |
| Technical Specifications | Not explicitly stated as acceptance criteria but implied to be comparable to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set data, sample size, or data provenance (e.g., country of origin, retrospective/prospective) are provided in this 510(k) summary. The submission focuses on substantial equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No ground truth was established from an expert panel for this submission as a "performance data" study was not conducted. The determination was based on substantial equivalence to existing devices.
4. Adjudication Method for the Test Set
Not applicable. No test set or adjudication method was used for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC comparative effectiveness study in the provided document. The device's approval was based on substantial equivalence, not a clinical effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a laser system, not an algorithm or AI-driven diagnostic tool. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
No direct ground truth was established through clinical data for the Lotus II Pulsed Er:YAG Laser System. The "ground truth" for its acceptance was the established safety and effectiveness of the predicate devices to which it claims substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device seeking 510(k) clearance based on substantial equivalence to predicate devices, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process described.
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5.0 510(K) SUMMARY
MAY 15 2009
| Applicant: | LASEROPTEK.CO. LTD |
|---|---|
| Address: | 204 Hyundai I Valley223-12 Sangdaiwon, JungwonSungnam, Kyunggi 462-714South Korea |
| Contact Person: | Dr. Hong Chu (President) |
| Telephone / Fax / E-mail: | Tel) 82.31.737.9885~8Fax) 82.31.737.9889E-mail) hchu@laseroptek.com |
| Submitter: | DPS International |
| Address: | 22750 Hawthorne Blvd., Suite 211Torrance, CA 90505 |
| Contact Person: | Phillip D. Cheon |
| Telephone / Fax / E-Mail: | Tel) 310.378.7545Fax) 310.378.8186E-mail) phillip@dpsii.com |
| Preparation Date: | September 16, 2008 |
| Device Trade Name: | Lotus II Pulsed Er:YAG Laser System |
| Common Name: | Er:YAG Pulsed Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered laser, 79-GEX, 2CFR 878-4810 |
| Legally Marketed Predicate Devices: | • DermaStar Er:YAG Laser System (K014057) byAsclepion-Meditec AG |
| • MCL 30 Dermablate Er:YAG Laser System(K042968) by Cynosure, Inc. | |
| Description of the Lotus II PulsedEr:YAG Laser System: | The Lotus II laser system is an Erbium:YAG laserwith a wavelength of 2.94 um. Laser activation is byfootswitch. Three basic elements of operations are asfollows:1) A Er:YAG crystal is used as a gain mediumwhich produces a laser beam.2) A resonator then amplifies the beam.3) A lamp that contains Xe gas is used, as apumping light source. The lamp requires ahigh-pressure power source device foroperation. When the electric energygenerated from the high-pressure powersource is induced into the electrode of thelamp, it converts into light energy. Thisconverted light energy pumps the Er:YAGcrystal – a gain medium – and the lightexhausted from the crystal is amplified into aspecific wavelength light. As it passesbetween the resonant gases, laser beamradiates to an output unit. |
| Intended Use of the Lotus II PulsedEr:YAG Laser System: | The Lotus II Pulsed Er:YAG Laser System is apulsed erbium doped yttrium-aluminum-garnet(Er:YAG) laser. It outputs laser light with awavelength of 2940 nm, a wavelength veryefficiently absorbed by the skin. It is intended forcoagulation, vaporization, ablation and/or cutting ofsoft tissue (skin) in dermatology, plastic surgery(including aesthetic surgery), and ophthalmology(skin around the eyes). This includes skinresurfacing and the treatment of wrinkles |
| Performance Data: | None |
| Conclusion: | The spec and intended uses of the Lotus II PulsedEr:YAG Laser System are the same or very similar tothose of claimed predicate devices. Because of this,performance data were not required. The Lotus IIPulsed Er:YAG Laser System is substantiallyequivalent to legally marketed devices. |
| The Lotus II Pulsed Er:YAG Laser System is anothersafe and effective device for coagulation,vaporization, ablation or cutting of soft tissue (skin)in dermatology, plastic surgery (including aestheticsurgery, and ophthalmology (skin around the eyes). |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of several curved lines that create a sense of movement and energy. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.
Public Health Service
MAY 15 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laseroptek Co., Ltd. % DPS International Mr. Phillip Cheon 22750 Hawthorne Boulevard, #211 Torrance, California 90505
Re: K083253
Trade/Device Name: Lotus II Pulsed Er: Y AG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 12, 2009
Received: March 17, 2009
Dear Mr. Cheon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
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Page 2 - Mr. Phillip Cheon
(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Madl M Milburn
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083253
Device Name:
Lotus II Pulsed Er:YAG Laser System
Indications For Use:
The Lotus II 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).
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
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rrence of CDRH, Office of Device Evaluation (ODE)
For mx ~
ision Sien-Division of Surpical, Orthopedie, and Restorative Devices
510(k) Number
§ 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.