(52 days)
Not Found
No
The document describes a laser system for soft tissue treatment and does not mention any AI or ML components or functionalities.
No.
The device's description of "coagulation, vaporization, ablation, or cutting of soft tissue" indicates it is used for surgical procedures, not therapeutic purposes.
No
Explanation: The intended use of the Lite Touch Erbium Laser Treatment System is for "coagulation, vaporization, ablation, or cutting of soft tissue," which are treatment procedures, not diagnostic ones.
No
The device description clearly states it is an Erbium:YAG laser, which is a hardware device that emits energy.
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 in dermatology and plastic surgery." This describes a direct therapeutic or surgical intervention on the patient's body, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description of the device as an "Erbium:YAG laser" further supports its function as a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to help diagnose diseases or conditions. This laser system operates directly on the patient's tissue for therapeutic or surgical purposes.
N/A
Intended Use / Indications for Use
"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."
Product codes
GEX
Device Description
The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K954013 and K952554, K961748 and K970394
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
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 Road |
| Danbury, CT 06810 | |
| Contact Person: | Mr. Wally Orlow |
| Vice President, Laser Division | |
| Telephone: | 203-731-8400 |
| 203-731-8440 (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; Erbium |
| Laser | |
| Classification | |
| Name | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology (see: 21 CFR 878.4810). | |
| Product Code: | |
| GEX; Panel 79. | |
| Predicate Devices: | Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser, and the |
| Continuum Biomedical, Inc., Multilite Erbium Laser and CB Erbium | |
| 2.94™ Systems. | |
| Device Description: | The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its |
| energy at 2.94um. See below for additional specifications. | |
| Intended Use: | 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. |
1
| TriLase Laser: | The SEO Medical TriLase 2940 is indicated for use in a variety of
surgical specialties, including cutting (incision/excision), vaporizing and
coagulating soft tissues. All soft tissues encountered in surgical
procedures 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. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multilite Laser: | The Multilite laser information includes "Cosmetic laser surgery...[is]
primarily restricted to applications in dermatology, plastic surgery, and
aesthetic surgery.")
The Multilite Laser was recently found substantially to itself for use in
skin resurfacing. The information includes the following specification:
At 5 pulses per second and a pulse energy of 2 Joules, the average Power
from the laser is 10 watts. |
| Performance Data: | 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. |
| CONCLUSION: | The Lite Touch Erbium Laser Treatment Laser System is substantially
equivalent to legally marketed predicate devices, i.e., the Schwartz
Electro-Optics, Inc. TriLase 2940 erbium laser (K954013 and K952554))
and the Continuum Biomedical, Inc. Multilite erbium laser and CB
Erbium 2.94™ Er-YAG Laser systems (K961748 and K970394) |
:
2
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
3
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
4
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