(265 days)
Not Found
Not Found
No
The document describes a laser treatment system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for medical purposes such as skin resurfacing, treating dermal pigmented lesions, and tattoo removal, which are all therapeutic applications.
No
The device description focuses on treatment (hair removal, skin resurfacing, lesion/tattoo removal) and does not mention any function for identifying, diagnosing, or characterizing medical conditions. Its purpose is to alter tissue, not to inform a diagnosis.
No
The device description explicitly states it is a "Laser Treatment System" and a "Q-Switched Nd:YAG," which are hardware components.
Based on the provided information, the LT-100 Laser Treatment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended uses listed are for direct treatment of the human body (hair removal, skin resurfacing, treating pigmented lesions, tattoo removal). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a laser system that emits energy, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the LT-100 Laser Treatment System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LT-100 Laser Treatment System is intended for use:
alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;
in combination with an adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;
dermal pigmented lesions (dermal melanocytosis); and
for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.
The LT-100 will be limited to use by licensed professionals (as provided in 21 CFR 801.109).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LT-100 Laser Treatment System is a Q-Switched Nd:YAG which emits its energy at 1064 nm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial or body hair, epidermal skin layers, dermal pigmented lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed professionals (as provided in 21 CFR 801.109)
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 LT-100 Laser Treatment Performance Data: System are the same as 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ThermoLase SoftLight, Continuum Biomedical, Inc., Medlite™ and Medlite™ IV Q-Switched Nd:YAG Lasers.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
长992597
APPENDIX D
SUMMARY OF SAFETY AND EFFECTIVENESS
LT-100 Q-SWITCHED ND: YAG LASER TREATMENT SYSTEM
This 510(k) summary of safety and effectiveness for the LT-100 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: | Focus Medical LLC |
|---|---|
| Address: | 19 Silver Spring Park |
| Ridgefield, CT 06810 | |
| Contact Person: | Mr. John Lee |
| President | |
| Telephone: | 203-438-1120 |
| 203-438-3169 (Fax) | |
| Preparation Date: | April 2000 |
| Device Trade Name: | LT-100 Laser Treatment System |
| Common Name: | Neodymium: Yttrium, Aluminum; Garnet (Nd:YAG) Laser System; |
| Q-Switched Nd:YAG 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: | ThermoLase SoftLight, Continuum Biomedical, Inc., Medlite™ and |
| Medlite™ IV Q-Switched Nd:YAG Lasers. | |
| Device Description: | The LT-100 Laser Treatment System is a Q-Switched Nd:YAG which |
| emits its energy at 1064 nm. |
1
The LT-100 Laser Treatment System is intended for use:
alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;
in combination with an adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;
dermal pigmented lesions (dermal melanocytosis); and
for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF.
The LT-100 will be limited to use by licensed professionals (as provided in 21 CFR 801.109).
None. The specifications and intended uses of the LT-100 Laser Treatment Performance Data: System are the same as 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 LT-100 Laser Treatment Laser System is substantially equivalent to legally marketed predicate devices, i.e., the ThermoLase SoftLight and the Continuum Biomedical, Inc., Medlite™ and Medlite™ IV Q-Switched Nd: YAG Lasers.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
APR 2 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Lee President Focus Medical, LLC 39 Silver Spring Park Ridgefield, Connecticut 06877
Re: K992597
Trade Name: LT-100 Laser Treatment System Regulatory Class: II Product Code: GEX Dated: February 15, 2000 Received: February 17, 2000
Dear Mr. Lee:
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 requirement, 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. John Lee
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 your 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,
vonne R. Lochner.
1/\ 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 B Rev. 4/2000
INDICATIONS FOR USE STATEMENT
K992597 510(K) Number (if known): __
Device Name: Lorad LT-100 Laser Treatment System --------
Indications For Use Statement:
The Lorad LT-100 Laser Treatment System is intended for use:
alone or in combination with an adjuvant lotion for the removal or lightening of unwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion;
in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery;
dermal pigmented lesions (dermal melanocytosis); and
for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF
The Lorad LT-100 Laser Treatment System will be limited to use by licensed professionals (as provided in 21 CFR 801.109).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use N (Per 21 CFR 801. 109) OR
Over-The-Counter Use
e R. Kocher.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992597