(52 days)
The Lite Touch Erbium Laser Treatment System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.
The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.
This document, K974460, is a 510(k) summary for the Lite Touch Erbium Laser Treatment System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.
Therefore, the following information is largely not available in the provided text:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided because no performance data was deemed required for this 510(k) submission. The submission states, "None. The specifications and intended uses of the Lite Touch Erbium Laser Treatment System are the same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."
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Sample size used for the test set and the data provenance: Not applicable, as no performance study was conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study was conducted.
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Adjudication method for the test set: Not applicable, as no performance study was conducted.
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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 device is a laser system, not an AI-assisted diagnostic tool.
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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.
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The type of ground truth used: Not applicable, as no performance study was conducted.
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The sample size for the training set: Not applicable, as no machine learning algorithm or training set is mentioned for this device.
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How the ground truth for the training set was established: Not applicable, as no machine learning algorithm or training set is mentioned for this device.
Key takeaway from the document:
The regulatory strategy for the Lite Touch Erbium Laser Treatment System was to demonstrate substantial equivalence to already legally marketed predicate devices (Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and Continuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium 2.94™ Systems). This approach meant that a new de novo performance study with specific acceptance criteria was not required by the FDA. The submission focused on comparing the specifications and intended uses of the new device to those of the predicate devices.
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APPENDIX G
SUMMARY OF SAFETY AND EFFECTIVENESS
JAN 1 6 1998
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM
This 510(k) summary of safety and effectiveness for the Lite Touch Erbium Laser Treatment System was prepared using guidance from the Office of Device Evaluation and is intended to comply with the requirements of SMDA 1990.
| Applicant: | Lorad |
|---|---|
| Address: | 36 Apple Ridge RoadDanbury, CT 06810 |
| Contact Person: | Mr. Wally OrlowVice President, Laser Division |
| Telephone: | 203-731-8400203-731-8440 (Fax) |
| Preparation Date:(of the Summary) | November 1997 |
| Device Trade Name: | Lite Touch Erbium Laser Treatment System |
| Common Name: | Erbium: Yttrium, Aluminum; Garnet (Er:YAG) Laser System; ErbiumLaser |
| ClassificationName | Laser surgical instrument for use in general and plasticsurgery and in dermatology (see: 21 CFR 878.4810).Product Code:GEX; Panel 79. |
| Predicate Devices: | Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and theContinuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium2.94™ Systems. |
| Device Description: | The Lite Touch Erbium Laser is an Erbium:YAG laser which emits itsenergy at 2.94um. See below for additional specifications. |
| Intended Use: | The Lite Touch Erbium Laser Treatment System is intended for thecoagulation, vaporization, ablation, or cutting of soft tissue indermatology and plastic surgery, including aesthetic surgery andresurfacing. |
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| TriLase Laser: | The SEO Medical TriLase 2940 is indicated for use in a variety ofsurgical specialties, including cutting (incision/excision), vaporizing andcoagulating soft tissues. All soft tissues encountered in surgicalprocedures are included in this indication, such as, but not limited to,skin, subcutaneous tissue, striated and smooth tissue, muscle, meniscus,mucous membrane, lymph vessels and nodes, organs and glands.Surgical specialties include dermatology, plastic surgery. |
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| Multilite Laser: | The Multilite laser information includes "Cosmetic laser surgery...[is]primarily restricted to applications in dermatology, plastic surgery, andaesthetic surgery.")The Multilite Laser was recently found substantially to itself for use inskin resurfacing. The information includes the following specification:At 5 pulses per second and a pulse energy of 2 Joules, the average Powerfrom the laser is 10 watts. |
| Performance Data: | None. The specifications and intended uses of the Lite Touch ErbiumLaser Treatment System are the same or very similar (substantiallyequivalent) to those of the claimed predicate devices. There are nosignificant differences between the devices under conditions of intendeduse.Because of this, performance data were not required. |
| CONCLUSION: | The Lite Touch Erbium Laser Treatment Laser System is substantiallyequivalent to legally marketed predicate devices, i.e., the SchwartzElectro-Optics, Inc. TriLase 2940 erbium laser (K954013 and K952554))and the Continuum Biomedical, Inc. Multilite erbium laser and CBErbium 2.94™ Er-YAG Laser systems (K961748 and K970394) |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 1998
Mr. Wally Orlow 'Vice President, Laser Division Lorad Corporation A Division of Trex Medical Corporation 36 Apple Ridge Road Danbury, Connecticut 06810
Re: K974460
Trade Name: Lite Touch Erbium Laser Treatment System Regulatory Class: II Product Code: GEX Dated: November 21, 1997 Received: November 25, 1997
Dear Mr. Orlow:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with-the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Mr. Orlow
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX D
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):_K974460
Device Name: Lite Touch Erbium Laser System
Indications For Use Statement:
"The Lite Touch Erbium Laser System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
D - 1
(Division Sign-Off) /
Division of General Restorative Devices
510(k) Number K974460
§ 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.