(190 days)
Not Found
No
The provided text describes a laser system with user-controlled parameters and standard safety compliance. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is a laser system indicated for various medical procedures such as coagulation, vaporization, cutting of soft tissue, and skin resurfacing, which are all therapeutic interventions aimed at treating or alleviating medical conditions.
No
The device is indicated for therapeutic procedures such as coagulation, vaporization, or cutting of soft tissue, and skin resurfacing treatment, rather than for diagnosing conditions.
No
The device description clearly states it is a laser system that produces a pulsed beam of light and includes hardware components like an articulated arm, handpiece, and footswitch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The ACTION II Laser System is a surgical laser that directly interacts with soft tissue (skin and other tissues) for coagulation, vaporization, or cutting. It is used for therapeutic and cosmetic procedures.
- Lack of Specimen Analysis: The description does not mention the device analyzing any biological specimens taken from the patient. It operates directly on the patient's body.
Therefore, the ACTION II Laser System falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACTION II Laser System is indicated for: coagulation, vaporization or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; keratoses; scar revision (including acne scars).
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin), skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a family of three figures, representing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2017
Lutronic Corporation Jhung Vojir VP. Ouality And Regulatory Affairs 6 Neshaminy Interplex, Suite 100 Trevose, Pennsylvania 19053
Re: K163196
Trade/Device Name: ACTION II 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. ONG Dated: May 12, 2016 Received: May 15, 2016
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 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
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 (QS) 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 -S
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) K163196
Device Name ACTION II Laser System
Indications for Use (Describe)
The ACTION II Laser System is indicated for: coagulation, vaporization or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; keratoses; scar revision (including acne scars).
| 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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510(k) Summary Lutronic ACTION II Laser System
This 510(k) Summary is being submitted in accordance with 21 CFR § 807.92.
| 1. Submitter's 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 | |
| Six Neshaminy Interplex, Suite 100 | |
| Trevose, PA 19053 | |
| Telephone: 215-205-2219 | |
| Fax: 609-488-6958 | |
| Email: jvojir@lutronic.com | |
| Date Prepared: | May 22, 2017 |
| 2. Device Information | |
| Trade Name: | ACTION II Laser System |
| Common Name: | Medical Laser System |
| Classification Name: | Powered Laser Surgical Instrument |
| Product Code: | GEX, ONG |
| Panel: | General and Plastic Surgery |
3. Predicate Devices
| 510(K) Number | K153229 | K150140 |
|---|---|---|
| Company Name | Bios S.R.L. | Asclepion Laser |
| Technologies, GmbH |
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| Device Name | Superbium | MCL 31 Dermablate |
|---|---|---|
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| Regulatory Class | II | II |
| Product Code | GEX, ONG, ONF | GEX |
4. Device Description
The ACTION II Laser System produces a pulsed beam of coherent near-infrared (2940 nm) light upon activation by a footswitch. The beam is then directed to the treatment zone by means of an articulated arm coupled to a handpiece. An integrated LCD touch screen gives the user control over the necessary laser system parameters. An aiming beam is coincident with the 2940 nm main laser beam.
5. Indications for Use
The ACTION II Laser System is indicated for: coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).
The ACTION II Laser Module Fractional Handpiece is indicated for: use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and Plastic Surgery: skin resurfacing treatment of wrinkles; epidermal nevi; telangiectasia; spider veins; actinic chelitis; keloids; verrucae; skin tags; anal tags; keratoses; scar revision (including acne scars).
6. Substantial Equivalence
The ACTION II Laser System is substantially equivalent to the legally marketed Superbium and MCL 31 Dermablate.
| Manufacturer | Lutronic Corporation | Bios S.R.L. | Asclepion Laser
Technologies, GmbH |
|-----------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Device Name | ACTION II Laser System | Superbium
(Primary Predicate) | MCL 31 Dermablate |
| 510(k) # | K163196 | K153229 | K150140 |
| Indications for Use | The ACTION II Laser
System is indicated for:
coagulation, vaporization,
ablation or cutting of soft | The 2940 nm Er:YAG Laser
Module handpiece is indicated
for: Coagulation, vaporization,
ablation or cutting of soft tissue | The MCL 31 Dermablate
laser system is intended for
coagulation, vaporization,
ablation or cutting of soft |
| | tissue (skin) in Dermatology,
Plastic Surgery, Oral
Surgery, ENT, Gynecology, | (skin) in Dermatology, Plastic
Surgery, Oral Surgery, ENT,
Gynecology, General Surgery, | tissue (skin) in
Dermatology, Plastic
Surgery, Oral Surgery, |
| | General Surgery, Podiatry | Podiatry and Ophthalmology | ENT, Gynecology, General |
| | and Ophthalmology (skin | (skin around the eyes). | Surgery, Podiatry and |
| | around the eyes). | Laser skin resurfacing | Ophthalmology (skin |
| | | procedures for the treatment of: | around the eyes). |
| | The ACTION II Laser | • Acne scars | |
| | Module Fractional | • Wrinkles | |
| | Handpieces are indicated for: | | |
| | use in soft tissue (skin, | The 2940 nm Er:YAG | |
| | cutaneous tissue,
subcutaneous tissue, striated | Fractional tips are indicated
for: use in soft tissue (skin, | |
| | and smooth tissue, muscle, | cutaneous tissue, subcutaneous | |
| | cartilage meniscus, mucous | tissue, striated and smooth | |
| | membrane, lymph vessels | tissue, muscle, cartilage | |
| | and nodes; organs, and | meniscus, mucous membrane, | |
| | glands) such as, but not | lymph vessels and nodes; | |
| | limited to: Dermatology and | organs, and glands) such as, but | |
| | Plastic Surgery: skin | not limited to: Dermatology | |
| | resurfacing treatment of | and Plastic Surgery: skin | |
| | wrinkles; epidermal nevi; | resurfacing treatment of | |
| | telangiectasia; spider veins; | wrinkles; epidermal nevi; | |
| | actinic chelitis; keloids; | telangiectasia; spider veins;
actinic chelitis; keloids; | |
| | verrucae; skin tags; anal
tags; keratoses; scar revision | verrucae; skin tags; anal tags; | |
| | (including acne scars). | keratoses; scar revision | |
| | | (including acne scars). | |
| Classification | GEX 21 CFR 878.4810, | GEX 21 CFR 878.4810, ONF | GEX 21 CFR 878.4810 |
| | ONF 21 CFR 878.4810 | 21 CFR 878.4810 | |
| Laser Source | Er: YAG | Er: YAG | Er: YAG |
| Wavelength | 2940 nm | 2940 nm | 2940 nm |
| Weight of Laser | 86.5 kg | 35 kg | 75 kg |
| Power max | 22W | 12 W | 20W |
| Energy max | 2.2 J | 2.5 J | 2.5 J |
| Pulse Width | 200 – 300 µs | 200-2200 µs | 100-1000 µs |
| Spot Size | 1-14 mm | 1 - 9 mm | 1-12 mm |
| Frequency max | 20 Hz | 5 Hz | 20 Hz |
| Fluence max | 280 J/cm² (spot 1 mm) | 316 J/cm² (spot 1 mm) | 318 J/cm² (spot 1 mm) |
| | | | |
| Module Fractional Handpiece | | | |
| Beam Diameter (dots) | 9x9 | 7x7, 9x9 | |
| Fluence | 13 mJ/dot | 13 mJ/dot | |
| Number of Dots | 81 dots/cm² | 81 dots/cm² (9x9) | |
| Max Frequency | 5 Hz | 5 Hz | |
| Max Power | 12 W | 12 W | |
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6
7. Non-Clinical Performance Data
The ACTION II Laser System complies with the following standards: IEC 60601-1 2005 + 1 (2006) + CORR 2 (2007) + AM1 (2012) or IEC 60601-1 2012. Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2 (Third Edition, 2007), Medical Electrical Equipment-Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility.
IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
8. Clinical Performance Data
None.
9. Conclusion
The ACTION II Laser System and the legally marketed Superbium cleared under 510(k) number K153229 have the same intended use and Indications for Use statement. Any technological differences between the ACTION II Laser System and its predicate devices are considered minor and do not raise any different types of questions regarding safety or effectiveness when used according to its intended use. The ACTION II Laser System is substantially equivalent to the predicate devices.