(146 days)
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.)
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 intuitive, 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).
This FDA document (K173067) is a 510(k) premarket notification for the LiteCure LightForce LTS laser systems. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a standalone study with a defined ground truth and statistical analysis of performance metrics like sensitivity and specificity.
Therefore, the document does not contain the detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or ground truth methodologies for clinical efficacy beyond a general statement of "no new safety and efficacy issues are raised" and "analyses demonstrate that system accuracy and performance are adequate for the established intended use."
The document focuses on comparing technological characteristics and indications for use of the new device to those of predicate devices to establish substantial equivalence.
Here's what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for clinical performance, nor does it report specific clinical performance metrics of the device against such criteria. The "performance" discussed is primarily in the context of technological characteristics being comparable to predicate devices.
The document states: "Analyses demonstrate that system accuracy and performance are adequate for the established intended use." and "no new safety and efficacy issues are raised with this new device." This is a general statement rather than specific, quantifiable performance data against acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specific sample size used to evaluate the device's clinical performance.
- Data Provenance: Not specified. There is no mention of country of origin or whether any data reviewed was retrospective or prospective in the context of a clinical performance study for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. As no specific clinical test set and ground truth establishment process for performance evaluation are described, this information is not present.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/Not specified. No clinical test set or adjudication process is described.
5. 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:
- MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical laser device, not an algorithm. Its "performance" would relate to its physical outputs (power, wavelength, etc.) and safety, which were assessed through verification and validation testing, not typically through a standalone algorithm performance study.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable/Not specified for clinical performance. For the purpose of a 510(k), the "ground truth" for substantial equivalence often involves comparing the specifications and intended use of the new device to existing predicate devices already cleared by the FDA. When it comes to device safety and functionality, engineering verification and validation testing would use established standards and measurement techniques as their "ground truth". The document mentions "verification and validation performance testing" but does not detail the "ground truth" for clinical efficacy.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified. This is a hardware laser device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/Not specified. As this is not an AI model, a training set and its ground truth are not relevant to this submission.
Summary of what the document does describe regarding "acceptance criteria" and "study":
The "study" in this context refers to verification and validation testing of the device's technical specifications and safety according to recognized standards, rather than a clinical trial measuring efficacy or diagnostic performance against a ground truth.
- Acceptance Criteria: Implicitly, the acceptance criteria are that the device's technological characteristics (wavelength, output power, etc.), safety features, and intended uses are substantially equivalent to those of the predicate devices. The document does not list explicit numerical acceptance criteria for clinical efficacy.
- Reported Device Performance (Technological Characteristics - comparison to predicates):
| General Characteristic | LightForce LTS Models | Predicate Device (Power Medic K070516) | Predicate Device (GBOX-15A/B, VELAS II K151890) | Predicate Device (LTS-1500 K123014) |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm | 808 nm | GBOX-15A: 810nm±10nm; GBOX-15B: 980nm±10nm; VELAS II-30A/60A: 810nm±10nm; VELAS II-30B/60B: 980nm±10nm; VELAS II-60C: 940nm±10nm | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm |
| Output Power | ≤10W, ≤15W, ≤25W, ≤40W | 300-1500 mW | 1-15 W, 30 W, 60 W | ≤25W |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5 mW ± 0.5 mW | N/A (not listed for Power Medic) | Red Diode Laser of 635 nm, Power < 5 mW | Red Diode Laser, 650 nm ± 20 nm, 3.5 mW ± 0.5 mW |
| Pulse Duration | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1, 0.05 milliseconds, OR per Built-in Protocols | N/A (≤2.5s listed for GBOX/VELAS) | ≤2.5s | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1, 0.05 milliseconds, OR per Built-in Protocols |
| Repetition Rate | up to 10 KHz | N/A (not listed for Power Medic) | 0.2 Hz - 20 KHz | up to 10 KHz |
| 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) | 245 mm (L) x 215 mm (W) x 315 mm (H) | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) |
| Weight | ≤10 kg | 7 oz (.2 kg) | 4 kg | ≤10 kg |
| Power Supply | 100-240 VAC; 50/60 Hz | Battery | GBOX: 100-240VAC, 200VA, 50-60Hz; VELAS II: various | N/A (not listed for LTS-1500) |
| Power Requirement | ≤400 - ≤600 VA | N/A (not listed for Power Medic) | GBOX: 200VA; VELAS II: 350VA or 650VA | N/A (not listed for LTS-1500) |
Study demonstrating equivalency:
The "study" cited is the submission of Verification and Validation Documentation. This documentation demonstrates that the updated LightForce LTS Models (1000, 1500, 2500, and 4000) have undergone testing to confirm their specifications, safety, and functionality. The conclusion is that these tests showed "system accuracy and performance are adequate for the established intended use" and that "no new safety and efficacy issues are raised," thus proving substantial equivalence to the predicate devices.
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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
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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
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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 BNewark, 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 WithOnychomycosis |
| Product Code: | PDZ |
| Regulation: | 21 CFR 878.4810 |
| Substantial equivalence claimed to: | |
| For Product Code ILYK070516 | Power Medic |
| For Product Code GEXK151890 | Medical Diode Laser System GBOX-15A/15B, VELAS II-60A/60B/60C |
| For Product Code PDZK123014 | 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.
| GeneralCharacteristic | LTS-1000 / 1500 / 2500 / 4000 | Power MedicK070516 | |
|---|---|---|---|
| Indication forUse | 810 nm and 980 nm wavelength:The LTS-1000/1500/2500/4000 devices emitenergy in the visible and near infraredspectrum to provide topical heating for thepurpose of elevating tissue temperature for atemporary relief of minor muscle and joint painand stiffness, minor arthritis pain, or musclespasm; the temporary increase in local bloodcirculation; and the temporary relaxation ofmuscle.980 nm wavelength:The LTS-2500/4000 devices are also indicatedfor use in surgical applications requiringhemostasis, ablation, vaporization, excision,incision, and coagulation of soft tissue inmedical 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 LaserAssisted Lipolysis.980 nm wavelength:The LTS-2500/4000 devices are also indicatedfor use for the temporary increase of clear nailin patients with onychomycosis (e.g.,dermatophytes Trichophyton rubrum andTrichophyton mentagrophytes, and/or yeastsCandida albicans, etc.) | The Power Laser is intended toemit energy in the visible andnear infrared spectrum toprovide topical heating for thepurpose of elevating tissuetemperature for a temporaryrelief of minor muscle and jointpain and stiffness, minor arthritispain, or muscle spasm; thetemporary increase in local bloodcirculation; the temporaryrelaxation 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.
| GeneralCharacteristic | LTS-1000 / 1500 / 2500 / 4000 | Power MedicK070516 |
|---|---|---|
| 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 at980 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 |
| GeneralCharacteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,VELAS II-60A/60B/60CK151890 |
|---|---|---|
| Indication forUse | 810 nm and 980 nm wavelength:The LTS-1000/1500/2500/4000devices emit energy in the visible andnear infrared spectrum to providetopical heating for the purpose ofelevating tissue temperature for atemporary relief of minor muscle andjoint pain and stiffness, minor arthritispain, or muscle spasm; the temporaryincrease in local blood circulation; andthe temporary relaxation of muscle.980 nm wavelength:The LTS-2500/4000 devices are alsoindicated for use in surgical applicationsrequiring hemostasis, ablation,vaporization, excision, incision, andcoagulation of soft tissue in medicalspecialties 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 AssistedLipolysis.980 nm wavelength:The LTS-2500/4000 devices are alsoindicated for use for the temporary | The "GBOX-15A/15B" are indicated foruse in surgical applications requiring thehemostasis, ablation, vaporization,excision, incision, and coagulation of softtissue in medical specialties including:aesthetic (dermatology and plasticsurgery), gastroenterology, generalsurgery, genitourinary surgery(urology), gynecology (GYN),neurosurgery, otolaryngology (ENT),ophthalmology, arthroscopy, podiatry,pulmonology, and thoracic surgery; andLaser Assisted Lipolysis (980 nm only).The "VELASII-30A/30B" are indicatedfor use in surgical applications requiringthe vaporization, incision, excision,ablation ,cutting and hemostasis ,orcoagulation of soft tissue in conjunctionwith endoscopic equipment for medicalspecialist including: Urology (BPH),Genitourinary (Urology), ThoracicSurgery, Plastic Surgery andDermatology, Aesthetics includingvascular lesions and hair removal,General Surgery, Ophthalmology,Orthopedics, Podiatry, Arthroscopy,Spinal Surgery, Gynecology, PulmonarySurgery. Neurosurgery (PLDD). |
| GeneralCharacteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,VELAS II-60A/60B/60CK151890 |
| increase of clear nail in patients withonychomycosis (e.g., dermatophytesTrichophyton rubrum and Trichophytonmentagrophytes, and/or yeasts Candidaalbicans, etc.) | Gastroenterology, Head/neck/ENT andRadiology Endovascular coagulation,Oral Surgery and Dental procedures,laser assisted lipolysis.The "VELASII-60A/60B/60C" areindicated for use in surgical applicationsrequiring the vaporization, incision,excision, ablation, cutting andhemostasis, or coagulation of soft tissue.Such as: Dermatology, Aesthetics, PlasticSurgery, Vascular Surgery, Podiatry,Endovenous Occlusion of the greatersaphenous vein of the thigh in patientswith superficial vein reflux. | |
| Product Code | GEX | GEX |
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20nm | GBOX-15A: 810nm±10nmGBOX-15B: 980nm±10nmVELAS II-30A, VELAS II-60A:810nm±10nmVELAS II-30B, VELAS II-60B:980nm±10nmVELAS II-60C:940nm±10nm |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5mW ± 0.5 mW | Red Diode Laser of 635 nm, Power < 5mW |
| Output Power | ≤10W ≤15W ≤25W ≤40W | 1-15 W 30 W 60 W |
| Pulse width | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1, 0.05milliseconds, OR per Built-in Protocols | ≤2.5s |
| RepetitionRate | up to 10 KHz | 0.2 Hz - 20 KHz |
| Dimensions | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) | 245 mm (L) x 215 mm (W) x 315 mm(H) |
| Weight | ≤10 kg | 4 kg |
| GeneralCharacteristic | LTS-1000 / 1500/ 2500 / 4000 | GBOX-15A/15B, VELASII-30A/30B,VELAS II-60A/60B/60CK151890 |
| Power Supply | 100-240 VAC; 50/60 Hz | GBOX-15A & 15B: 100-240VAC, 200VA,50-60Hz |
| VELASII-30A, VELAS II -30B: 100-240VAC, 50/60Hz, 350VA | ||
| VELAS II-60A, VELAS II-60B, VELAS II-60C: 100-240VAC, 50/60Hz, 650VA | ||
| PowerRequirement | ≤400 - ≤600 VA | GBOX-15A & 15B: 100-240VAC, 200VA |
| VELASII-30A, VELAS II -30B:350VA | ||
| VELAS II-60A, VELAS II-60B, VELAS II-60C: | ||
| 650VA |
LiteCure, LTS System 510(k) K173067,
RFI 11-28-2017 Response Document 002 Page 4 of 8
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Image /page/7/Picture/0 description: The image shows the logo for LiteCure, a company that specializes in lasers for life. The logo is written in a blue font, with the word "LITECURE" in large letters and the tagline "Lasers for Life" in smaller letters below. A horizontal line is underneath the word "LITECURE" and extends to the right, ending in a star.
LiteCure, LTS System 510(k) K173067,
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Image /page/8/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in large, bold letters. Below the word is the phrase "Lasers for Life" in a smaller font. To the right of the phrase is a small asterisk.
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Image /page/9/Picture/0 description: The image shows the logo for LiteCure. The logo is in blue and consists of the word "LITECURE" in a sans-serif font. Below the word "LITECURE" is the phrase "Lasers for Life" in a smaller font. A horizontal line extends from under the word "LITECURE" to the right, ending in a starburst symbol.
| Table 3: Technological Characteristics Compared to Predicate Device PDZ: | ||
|---|---|---|
| GeneralCharacteristic | LTS-1000 / 1500/ 2500 / 4000 | LTS-1500K123014 |
| Indication forUse | 810 nm and 980 nm wavelength:The LTS-1000/1500/2500/4000 devices emitenergy in the visible and near infraredspectrum to provide topical heating for thepurpose of elevating tissue temperature for atemporary relief of minor muscle and jointpain and stiffness, minor arthritis pain, ormuscle spasm; the temporary increase in localblood circulation; and the temporaryrelaxation of muscle.980 nm wavelength:The LTS-2500/4000 devices are alsoindicated for use in surgical applicationsrequiring hemostasis, ablation, vaporization,excision, incision, and coagulation of softtissue 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 LaserAssisted Lipolysis.980 nm wavelength:The LTS-2500/4000 devices are alsoindicated for use for the temporary increaseof clear nail in patients with onychomycosis(e.g., dermatophytes Trichophyton rubrumand Trichophyton mentagrophytes, and/oryeasts Candida albicans, etc.) | 810 nm and 980 nm:LiteCure Therapy System, ModelLTS-1500 is indicated for emittingenergy in the infrared spectrum toprovide topical heating for thepurpose of elevating tissuetemperature for temporary relief ofminor muscle and joint pain, musclespasm, pain and stiffness associatedwith arthritis and promotingrelaxation of the muscle tissue andto temporarily increase local bloodcirculation.980 nm:LiteCure Therapy System, ModelLTS-1500 is indicated for use for thetemporary increase of clear nail inpatients with onychomycosis (e.g.,dermatophytes Trichophytonrubrum and T. mentagrophytes,and/or yeasts Candida albicans,etc.). |
| Product Code | PDZ | PDZ |
| Laser Type | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm | 810 nm ± 20 nm AND/OR 980 nm ±20 nm |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5 mW ±0.5 mW | Red Diode Laser, 650 nm ± 20 nm,3.5 mW ± 0.5 mW |
| Output Power | ≤10W ≤15W ≤25W ≤40W | ≤25W |
| Pulse Duration | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1, 0.05milliseconds, OR per Built-in Protocols | 250, 50, 25, 5, 2.5, 1.0, 0.5, 0.2, 0.1,0.05 milliseconds, OR per Built-inProtocols |
| RepetitionRate | up to 10 KHz | up to 10 KHz |
| GeneralCharacteristic | LTS-1000 / 1500/ 2500 / 4000 | LTS-1500K123014 |
| Dimensions | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm (H) | 41.3 cm (L) x 26.4 cm (W) x 25.7 cm(H) |
| Weight | ≤10 kg | ≤10 kg |
LiteCure, LTS System 510(k) K173067,
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Verification and Validation Documentation:
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.
Conclusion:
This performance of the LightForce® LTS Model 1000, 1500, 2500, and 4000 is substantially equivalent to that of the PREDICATE Systems Power Medic K070516, Medical diode laser system GBOX-15A/15B, VELAS II-60A/60B/60C K151890, and LiteCure Therapy System Model LTS-1500 K123014.
We believe that the documentation and objective evidence provided demonstrates that the LightForce® LTS Model 1000, 1500, 2500, and 4000 has been demonstrated to be substantially equivalent to the predicate devices and raises no new concerns related to safety or efficacy.
§ 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.