(85 days)
Not Found
No
The summary describes a CO2 laser system for surgical procedures and does not mention any features or components related to AI or ML. The performance studies listed are standard electrical and laser safety tests.
Yes
The device is indicated for medical procedures such as incision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic actions. Additionally, the performance studies mention "therapeutic and diagnostic laser equipment," further supporting its therapeutic classification.
No
The device is indicated for surgical procedures (incision, ablation, vaporization, and coagulation) and skin resurfacing, which are therapeutic actions, not diagnostic ones.
No
The device description clearly lists hardware components such as a main console unit, delivery handpieces, and a footswitch, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on body soft tissues (incision, ablation, vaporization, coagulation). This is a direct intervention on the patient's body.
- Device Description: The device is a CO2 laser system with handpieces and a footswitch, designed for delivering laser energy to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of these samples.
The device is a surgical laser system used for therapeutic and aesthetic purposes, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG
Device Description
The Jeisys EdgeOne CO2 Laser is comprised of the following major components:
-
- The main console unit
-
- Delivery handpieces (2 surgical and one fractional)
-
- Footswitch.
- Accessories 4.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues
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)
Product testing performed included:
IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) Medical electrical equipment – General Requirements for Electrical Safety - NO DEVIATIONS
IEC 60601-2-22:2007 (Third Edition) + A1 (2012) for use with IEC 60601-1:2012 + A1 (2012) Medical Electrical Equipment - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC60601-1-2:2007 - Section 6, not life-supporting equipment, group 1&2, Class A - Medical Electrical Equipment PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The profiles are depicted in a simple, flowing line style.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2016
Jeisys Medical Inc. % Kathy Maynor Consultant Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, Florida 34446
Re: K162169
Trade/Device Name: EdgeOne CO2 Laser 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: July 30, 2016 Received: August 3, 2016
Dear Ms. Maynor:
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 (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 -A 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) K162169
Device Name Jeisys EdgeOne CO2 Laser
Indications for Use (Describe)
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
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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3
I. General Information
| Submitter: | JEISYS MEDICAL INC.
307 Daeryung Techno Town 8th
481-11, Gasan-Dong, Geumcheon-Gu
Seoul Seoul Teugbyeolsi, KOREA, REPUBLIC
OF 153-775 |
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Contact Person: | Kathy Maynor | |
|---|---|---|
| Consultant | ||
| 352-586-3113 (cell) | ||
| Summary Preparation Date: | July 29, 2016 |
II. Names
| Device Names: | The Jeisys EdgeOne CO2 Laser |
|---|---|
| Primary Classification Names: | Surgical Powered Light Instrument, |
III. Predicate Devices
| K # | Predicate Device |
|---|---|
| K100590 | EDGE CO2 LASER SYSTEM |
| K133895 | DEKA SMARTXIDE LASER SYSTEM |
IV. Product Description
The Jeisys EdgeOne CO2 Laser is comprised of the following major components:
-
- The main console unit
-
- Delivery handpieces (2 surgical and one fractional)
-
- Footswitch.
- Accessories 4.
V. Indications for Use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery
4
(including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
VI. Summary of Technical Characteristics
| Parameter | K16XXX
Jeisys Edge One Laser | K100590
Jeisys Edge One Laser
(Predicate Device) | K133895
Deka Smartxide 2
(Secondary Predicate) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code &
Regulation No. | GEX, ONG
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Laser Type | CO2 | CO2 | CO2 |
| Laser wavelength | 10.6µm | 10.6µm | 10.6µm |
| Output power | 30W | 30W | 60W |
| Pulse Duration | 1-1000ms | 1-1000ms | 100 2,000 µs |, 50/60Hz,
| Fractional Pulse
energy | 1-300mJ | 1-300mJ | Unknown |
| Repetition rate | 10-500Hz | 10-500Hz | 5Hz to 100Hz |
| Scan area | 15 x 15mm2 | 15 x 15mm2 | 15 x 15mm |
| Spot size (fractional) | 120um, 350um, 800um | 120um, 350um, 800um | 125µm, 155µm, 267µm,
325μm, 489µm, 530μm |
| Surgical handpieces | 0,15, 1 | NA | 0.15, 1, collimated,
dental |
| Operational mode | Fractional mode, normal
mode (CW, Pulse, Single
Pulse, Repeat, Group
pulse, Ultra) | Fractional mode, normal
mode (CW, Pulse, Single
Pulse, Repeat, Group
pulse, Ultra) | Fractional CW, SP, DP,
HP, UP
Normal
Interlaced
SmartTrack |
| Aiming beam | Diode laser(Red) 655 +/-
10nm, Max 1mW | Diode laser(Red) 655 +/-
10nm, Max 1mW | Diode laser (Red) 635nm,
4mW max |
| Fractional | Spot density 0-42.4% | Spot density 0-42.4% | Unknown |
| Cooling | Water | Water | Water |
| User Interface | LCD touch screen | LCD touch screen | LCD touch screen |
| Optical guide | Articulated arm | Articulated arm | Articulated arm |
| Electrical
Requirements | 230V
500VA(max. laser
output), 100 VA(stand-
by) | 230V~, 50/60Hz,
500VA(max. laser
output), 100 VA(stand-
by) | 100-120V~/220-230V~,
50/60Hz, 1600VA |
| Indications for Use | It is indicated for
incision, excision,
ablation, vaporization and
coagulation of body soft
tissues in medical
specialties including
aesthetic (dermatology
and plastic surgery),
podiatry,
otolaryngology(ENT),
gynaecology,
neurosurgery,
orthopaedics, general and
thoracic surgery
(including open and
endoscopic), dental and
oral surgery and
genitourinary surgery.
The use with the scanning
unit is indicated for
ablative skin resurfacing. | The Edge CO 2 laser
when used in traditional
non-fractionated scanner
mode is
indicated for incision,
excision, ablation,
vaporization, and
coagulation of body soft
tissues.
The Edge CO 2 laser
when used in
fractionated mode is
indicated for ablative
skin
resurfacing. | It is indicated for
incision, excision,
ablation, vaporization
and coagulation of body
soft tissues in medical
specialties including
aesthetic (dermatology
and plastic surgery),
podiatry,
otolaryngology(ENT),
gynaecology,
neurosurgery,
orthopaedics, general
and thoracic surgery
(including open and
endoscopic), dental and
oral surgery and
genitourinary surgery.
The use with the
scanning unit is indicated
for ablative skin
resurfacing. |
Table 1: Salient Characteristics of the Jeisys EdgeOne CO2 Laser and the Predicate Devices
5
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Jeisys EdgeOne CO2 laser is substantially equivalent to the predicate devices.
Product testing performed included:
IEC 60601-1:2005 + CORR.1 (2006) + CORR.2 (2007) Medical electrical equipment – General Requirements for Electrical Safety - NO DEVIATIONS
IEC 60601-2-22:2007 (Third Edition) + A1 (2012) for use with IEC 60601-1:2005 + A1 (2012) Medical Electrical Equipment - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC60601-1-2:2007 - Section 6, not life-supporting equipment, group 1&2, Class A - Medical Electrical Equipment PART 1: GENERAL REQUIREMENTS FOR SAFETY 2. COLLATERAL STANDARD: ELECTROMAGNETIC COMPATIBILITY - REQUIREMENTS AND TESTS
6
VIII. Conclusion
The Jeisys EdgeOne CO2 laser was found to be substantially equivalent to the predicate devices.
The Jeisys EdgeOne CO2 laser shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.