(146 days)
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No
The document describes a laser system with pre-set protocols and user-adjustable parameters, controlled by standard software and a GUI. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes.
The device is clearly indicated for therapeutic purposes such as "temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm" and "surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue."
No
The device is described as emitting energy to provide topical heating, increase blood circulation, and relax muscles for therapeutic purposes. It is also used for surgical applications and treatment of onychomycosis. There is no mention of the device being used to capture, process, or analyze any data or signals for the purpose of identifying a medical condition or disease.
No
The device description explicitly states it is a medical laser system with a Console Assembly, Laser Module Sub-Assembly, and Beam Delivery Assembly, all of which are hardware components. While it includes software for the GUI and control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to treating conditions or performing surgical procedures on the human body (topical heating for pain relief, increasing blood circulation, muscle relaxation, surgical applications, treating onychomycosis). IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device description focuses on delivering laser light to a subject via handpiece attachments. This is consistent with a therapeutic or surgical device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the LTS-1000/1500/2500/4000 devices are therapeutic/surgical medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY, PDZ
Device Description
The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitiye, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort.
Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The LightForce® LTS Model 1000, 1500, 2500, and 4000 tests include verification and validation performance testing as well as usability testing to demonstrate no new safety and efficacy issues are raised with this new device. Analyses demonstrate that system accuracy and performance are adequate for the established intended use. In conclusion, the modified LightForce® LTS Model 1000, 1500, 2500, and 4000 is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."
February 22, 2018
LiteCure, LLC Mr. Curtis Egan Principal Quality Engineer Certified Compliance Solutions, Inc. 11665 Avena Place Suite 203 San Diego, California 92128
Re: K173067
Trade/Device Name: LightForce LTS Model 1000, 1500, 2500, and 4000 Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: GEX, ILY, PDZ Dated: September 27, 2017 Received: September 29, 2017
Dear Curtis Egan:
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 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
Jennifer R. Stevenson -S3
For 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) K173067
Device Name
LightForce® LTS Model 1000, 1500, 2500, and 4000
Indications for Use (Describe)
810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and features the word "LITECURE" in a bold, sans-serif font. Below the word "LITECURE" is the tagline "Lasers for Life" in a smaller font. A horizontal line runs underneath the word "LITECURE" and extends to the right, ending in a starburst symbol.
250 Corporate Blvd, Suite B Newark, DE 19702
P | 302.709.0408 F | 302.709.0409 LiteCure.com
510(k) Summary
| Submitter: | LiteCure, LLC. |
|---|---|
| Address: | 250 Corporate Blvd. Suite B |
| Newark, DE 19702 | |
| Phone Number: | (302) 709-0408 |
| FDA Registration #: | 3006268867 |
| Contact Person: | Curtis M. Egan, Principal Quality Engineer |
| Phone Number: | (951) 723 7261 |
| Fax Number: | 858-675-8201 |
| Date prepared: | February 15, 2018 |
| Trade name: | LightForce® LTS Model 1000, 1500, 2500, and 4000 |
| Common Name: | Infrared Laser |
| Classification Name: | Lamp, Infrared, Therapeutic Heating |
| Product Code: | ILY |
| Regulation: | 21 CFR 890.5500 |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | GEX |
| Regulation: | 21 CFR 878.4810 |
| Classification Name: | Lasers For Temporary Increase Of Clear Nail In Patients With |
| Onychomycosis | |
| Product Code: | PDZ |
| Regulation: | 21 CFR 878.4810 |
| Substantial equivalence claimed to: | |
| For Product Code ILY | |
| K070516 | Power Medic |
| For Product Code GEX | |
| K151890 | Medical Diode Laser System GBOX-15A/15B, VELAS II-60A/60B/60C |
| For Product Code PDZ | |
| K123014 | LiteCure Therapy System Model LTS-1500 |
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Image /page/4/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and features the word "LITECURE" in a sans-serif font. Below the word is a horizontal line, and below the line is the phrase "Lasers for Life" in a smaller font. To the right of the phrase is a small asterisk.
Description:
The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitiye, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort.
Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).
Indications for Use:
810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
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Image /page/5/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in all caps, with a horizontal line underneath. Below the line, the words "Lasers for Life" are written in a smaller font. To the right of the words "Lasers for Life" is a small asterisk.
Technological Characteristics:
The underlying technology of the LightForce® LTS Model 1000, 1500, 2500, and 4000 is the same as the predicate devices Power Medic K070516, Medical diode laser system GBOX-15A/15B, VELAS II-60A/60B/60C K151890, and LiteCure Therapy System Model LTS-1500 K123014. The system is based on the same operating principle and control, mechanism to provide the user with the same kind of information and guidance for the same Procedures. The main changes with respect to the predicate device concern the modification to the user interface, safety controls and workflow.
| General
Characteristic | LTS-1000 / 1500 / 2500 / 4000 | Power Medic
K070516 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indication for
Use | 810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit
energy in the visible and near infrared
spectrum to provide topical heating for the
purpose of elevating tissue temperature for a
temporary relief of minor muscle and joint pain
and stiffness, minor arthritis pain, or muscle
spasm; the temporary increase in local blood
circulation; and the temporary relaxation of
muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated
for use in surgical applications requiring
hemostasis, ablation, vaporization, excision,
incision, and coagulation of soft tissue in
medical specialties including: aesthetic
(dermatology and plastic surgery),
gastroenterology, general surgery,
genitourinary surgery (urology), gynecology
(GYN), neurosurgery, otolaryngology (ENT),
ophthalmology, arthroscopy, podiatry,
pulmonology, thoracic surgery; and Laser
Assisted Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated
for use for the temporary increase of clear nail
in patients with onychomycosis (e.g.,
dermatophytes Trichophyton rubrum and
Trichophyton mentagrophytes, and/or yeasts
Candida albicans, etc.) | The Power Laser is intended to
emit energy in the visible and
near infrared spectrum to
provide topical heating for the
purpose of elevating tissue
temperature for a temporary
relief of minor muscle and joint
pain and stiffness, minor arthritis
pain, or muscle spasm; the
temporary increase in local blood
circulation; the temporary
relaxation of muscle. | |
| | Product Code | IIY | IIY |
Table 1: Technological Characteristics Compared to Predicate Device ILY:
LiteCure, LTS System 510(k) K173067,
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Image /page/6/Picture/0 description: The image is a logo for LiteCure Lasers for Life. The logo is in blue and features the word "LITECURE" in a bold, sans-serif font. Underneath the word is the phrase "Lasers for Life" in a smaller, sans-serif font. A horizontal line extends from under the word "LITECURE" to the right, ending in a starburst symbol.
| General
Characteristic | LTS-1000 / 1500 / 2500 / 4000 | Power Medic
K070516 |
|---------------------------|-------------------------------------------------------|---------------------------------------------|
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm | 808 nm |
| Output power | 5 W at 810 nm and 20 W at 980 nm OR 25 W at
980 nm | 300-1500 mW |
| Dimensions | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) | 9 in (22.9 cm) (L) x 1.5 in (3.8 cm)
(W) |
| Weight | ≤10 kg | 7 oz (.2 kg) |
| Power Supply | 100-240 VAC; 50/60 Hz | Battery |
| General
Characteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,
VELAS II-60A/60B/60C
K151890 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | 810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000
devices emit energy in the visible and
near infrared spectrum to provide
topical heating for the purpose of
elevating tissue temperature for a
temporary relief of minor muscle and
joint pain and stiffness, minor arthritis
pain, or muscle spasm; the temporary
increase in local blood circulation; and
the temporary relaxation of muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also
indicated for use in surgical applications
requiring hemostasis, ablation,
vaporization, excision, incision, and
coagulation of soft tissue in medical
specialties including: aesthetic
(dermatology and plastic surgery),
gastroenterology, general surgery,
genitourinary surgery (urology),
gynecology (GYN), neurosurgery,
otolaryngology (ENT), ophthalmology,
arthroscopy, podiatry, pulmonology,
thoracic surgery; and Laser Assisted
Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also
indicated for use for the temporary | The "GBOX-15A/15B" are indicated for
use in surgical applications requiring the
hemostasis, ablation, vaporization,
excision, incision, and coagulation of soft
tissue in medical specialties including:
aesthetic (dermatology and plastic
surgery), gastroenterology, general
surgery, genitourinary surgery
(urology), gynecology (GYN),
neurosurgery, otolaryngology (ENT),
ophthalmology, arthroscopy, podiatry,
pulmonology, and thoracic surgery; and
Laser Assisted Lipolysis (980 nm only).
The "VELASII-30A/30B" are indicated
for use in surgical applications requiring
the vaporization, incision, excision,
ablation ,cutting and hemostasis ,or
coagulation of soft tissue in conjunction
with endoscopic equipment for medical
specialist including: Urology (BPH),
Genitourinary (Urology), Thoracic
Surgery, Plastic Surgery and
Dermatology, Aesthetics including
vascular lesions and hair removal,
General Surgery, Ophthalmology,
Orthopedics, Podiatry, Arthroscopy,
Spinal Surgery, Gynecology, Pulmonary
Surgery. Neurosurgery (PLDD). |
| General
Characteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,
VELAS II-60A/60B/60C
K151890 |
| | increase of clear nail in patients with
onychomycosis (e.g., dermatophytes
Trichophyton rubrum and Trichophyton
mentagrophytes, and/or yeasts Candida
albicans, etc.) | Gastroenterology, Head/neck/ENT and
Radiology Endovascular coagulation,
Oral Surgery and Dental procedures,
laser assisted lipolysis.
The "VELASII-60A/60B/60C" are
indicated for use in surgical applications
requiring the vaporization, incision,
excision, ablation, cutting and
hemostasis, or coagulation of soft tissue.
Such as: Dermatology, Aesthetics, Plastic
Surgery, Vascular Surgery, Podiatry,
Endovenous Occlusion of the greater
saphenous vein of the thigh in patients
with superficial vein reflux. |
| Product Code | GEX | GEX |
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20
nm | GBOX-15A: 810nm±10nm
GBOX-15B: 980nm±10nm
VELAS II-30A, VELAS II-60A:
810nm±10nm
VELAS II-30B, VELAS II-60B:
980nm±10nm
VELAS II-60C:
940nm±10nm |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5
mW ± 0.5 mW | Red Diode Laser of 635 nm, Power