(80 days)
Not Found
No
The summary describes a laser system with standard controls and safety features. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on standard laser safety and efficacy comparisons to a predicate device.
Yes
The device is indicated for medical procedures such as the treatment of actinic keratosis and benign pigmented lesions, which are therapeutic interventions.
No
The device is described as a laser system for dermatological procedures requiring coagulation of soft tissue and treatment of lesions. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly states it is a laser system with hardware components like a thulium laser, optical fiber, handpiece, and footswitch.
Based on the provided information, the LASEMD Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for dermatological procedures requiring the coagulation of soft tissue and treatment of various skin lesions. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser system that emits light to treat tissue. This is a physical intervention, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LASEMD Laser System is a therapeutic device that directly treats tissue.
N/A
Intended Use / Indications for Use
The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.
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
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)
Bench Testing
The LASEMD Laser System complies with all applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
Animal Testing
Histology confirms that the treatment skin effect of the LASEMD Laser System is the same as the predicate Fraxel DUAL 1927 nm Laser System when used at the same energy settings.
Clinical Testing
No performance data has been provided since the LASEMD Laser System is equivalent to the previously cleared predicate device with no new issues regarding safety and effectiveness.
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.
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of three human profiles facing to the right, with a symbol resembling a caduceus or staff with a serpent intertwined.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
Lutronic Corporation Jhung Vojir VP, Quality and Regulatory Affairs 6 Neshaminy Interplex. Suite 100 Trevose, Pennsylvania 19053
Re: K171009
Trade/Device Name: LASEMD Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: April 3, 2017 Received: April 4, 2017
Dear Jhung Vojir:
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 Actinclude 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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) K171009
Device Name LASEMD Laser System
Indications for Use (Describe)
The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
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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Confidential and Proprietary Information of Lutronic Corporation
3
6. 510(k) SUMMARY OR STATEMENT
The Company's 510(k) Summary for the LASEMD Laser System is as follows:
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510(k) Summary Lutronic Corporation LASEMD Laser System
This 510(k) Summary is being submitted in accordance with 21 CFR § 807.92.
1. General Information
| Applicant: | Lutronic Corporation |
|---|---|
| 219 Sowon-ro | |
| Haengsin-dong, Deogyang-gu | |
| Goyang-si, Gyeonggi-do 410-220 | |
| Republic of Korea | |
| Tel: (82) 31-908-3440 | |
| FAX: (82) 31-907-3440 | |
| Contact Person: | Jhung Won Vojir, Ph.D. |
| VP of Quality and Regulatory Affairs | |
| Lutronic Corporation | |
| 6 Neshaminy Interplex, Suite 100 | |
| Trevose, PA 19053 | |
| Tel: 215-205-2219 | |
| FAX: 609-488-6958 | |
| Email: jvojir@lutronic.com | |
| Summary Preparation Date: | June 20, 2017 |
| 2. Names | |
| Trade Name: | LASEMD Laser System |
| Common Name: | Laser Surgical Instrument |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: GEX | |
| 21 CFR § 878.4810 | |
| Panel: General & Plastic Surgery |
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3. Predicate Device
The Fraxel DUAL Laser System is a surgical instrument for performing dermatological procedures in the treatment of actinic keratosis and treatment of pigmented lesions.
| 510(K) Number | K130193 |
|---|---|
| Company Name | Solta Medical, Inc. |
| Device Name | Fraxel DUAL 1550/1929 Laser System |
| Classification Regulation | 21 CFR § 878.4810 |
| Classification Name | Powered Laser Surgical Instrument |
| Product Code | GEX |
| Device Panel | General & Plastic Surgery |
4. Device Description
The LASEMD Laser System is a thulium laser, producing a pulsed beam of coherent near-infrared light (1927 nm) upon activation by a footswitch. The beam is then directed to the treatment zone by means of an optical fiber coupled to a handpiece. An integrated LED touch screen gives the user control over the necessary laser system parameters. The LASEMD Laser System is equipped with a 658 nm aiming beam.
5. Indications for Use
The LASEMD Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).
6. Substantial Equivalence
The LASEMD Laser System is substantially equivalent to the legally marketed Solta Medical Fraxel DUAL Laser System that is the subject of 510(k) K130193.
| Manufacturer | Lutronic Corporation | Solta Medical, Inc. |
|---|---|---|
| Device | LASEMD Laser System | Fraxel DUAL 1550/1927 |
| Laser System | ||
| 510(k) Number | K171009 | K130193 |
| Indications for Use | The LASEMD Laser System is | |
| indicated for use in | ||
| dermatological procedures | ||
| requiring the coagulation of | ||
| soft tissue, treatment of actinic | ||
| keratosis, and treatment of | ||
| benign pigmented lesions such | ||
| as, but not limited to lentigos | ||
| (age spots), solar lentigos (sun | ||
| spots) and ephelides (freckles). | 1927nm: The Fraxel 1927 nm | |
| laser is indicated for use in | ||
| dermatological procedures | ||
| requiring the coagulation of | ||
| soft tissue, treatment of actinic | ||
| keratosis, and treatment of | ||
| pigmented lesions such as, but | ||
| not limited to lentigos (age | ||
| spots), solar lentigos (sun | ||
| spots) and ephelides | ||
| (freckles). |
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| Classification | GEX, 21 CFR § 878.4810 | GEX, 21 CFR § 878.4810 |
|---|---|---|
| Laser Type | Thulium laser | Thulium laser |
| Laser Wavelength | 1927 nm | 1927 nm |
| Aiming Beam | 658 nm ≤ 5 mW | 658 nm ≤ 5 mW |
| Beam Delivery | Fiber and Handpiece | Fiber and Handpiece |
| Emission Control | Footswitch | Footswitch |
| Display Screen | Yes | Yes |
| Power | 5 W | 12 W (1927 nm) |
| Max Pulse Energy | 20 mJ | 20 mJ (1927 nm) |
| Max Pulse Width | 20 ms | 10 ms |
| Pulse Repetition Rate | 43.5 - 307.7 Hz | 0 - 3 kHz |
| Tip Size | 4 mm x 10 mm | Small tip: 7 mm |
| Large tip: 15 mm | ||
| Dimensions of Laser Console | 413 mm (W) x 324 mm (L) x | |
| 255.5 mm (D) | 489 mm (W) x 451 mm (L) x | |
| 444.5 mm (D) | ||
| Spot Size | 100 $ μ $ m, 200 $ μ $ m | 200 $ μ $ m |
| Weight of Laser System | 33.1 kg | 68.0 kg |
| Electrical Rating | AC 100-240V, 50/60 Hz, | |
| Power Consumption | AC 100-240V, 50/60 Hz, | |
| Power Consumption |
7. Performance Data
The Company's Performance Data for the LASEMD Laser System is as follows:
Bench Testing
The LASEMD Laser System complies with all applicable standards, including ISO 13485:2003, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
Animal Testing
Histology confirms that the treatment skin effect of the LASEMD Laser System is the same as the predicate Fraxel DUAL 1927 nm Laser System when used at the same energy settings.
Clinical Testing
No performance data has been provided since the LASEMD Laser System is equivalent to the previously cleared predicate device with no new issues regarding safety and effectiveness.
8. Conclusion
The LASEMD Laser System and the legally marketed Fraxel DUAL Laser System cleared under 510(k) number K130193, have the same intended use and Indications for Use statement. While the technological characteristics differ between the two systems, the differences have been established to be minor. Performance testing data established that the LASEMD Laser System is as safe and effective as the legally marked predicate
7
device and that the LASEMD Laser System does not raise any different questions of safety and effectiveness than the predicate. On this basis and in accordance with 21 CFR $ 807.100(b), the LASEMD Laser System is substantially equivalent to the Fraxel DUAL Laser System and can be legally marketed in the U.S.