(134 days)
Not Found
No
The document describes a laser system for soft tissue ablation and resurfacing, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
Yes
The device is indicated for various surgical applications, including skin resurfacing, treatment of wrinkles, and removal of skin lesions, all of which aim to treat medical conditions or symptoms, thus qualifying it as a therapeutic device.
No
The document describes the device's function for incision, ablation, vaporization, and coagulation of tissues, and for surgical applications, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a hardware system including a console, articulated arm, handpiece, touch screen, and footswitch, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body (in vitro).
- Device Function: The description clearly states that this device is a CO2 and Er: YAG laser system used for surgical procedures involving the incision, ablation, vaporization, and coagulation of body soft tissues and skin. These are procedures performed on the living body (in vivo).
- Intended Use: The intended use describes surgical applications and treatments performed directly on patients.
- Device Description: The description details a laser system with an articulated arm and handpiece for delivering laser energy to the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or any other activity associated with in vitro diagnostics.
Therefore, this device is a surgical laser system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, 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 CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- · Laser skin resurfacing.
- · Treatment of furrows and wrinkles.
- Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- · Blepharoplasty.
- · Site preparation for hair transplants.
- · The fractional scanner is for skin resurfacing.
The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissues, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
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)
Performance Data: None submitted.
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.
Cortex Laser System K110897, DEKA SmartXide2 Laser System K133895, C02-2B3 Galaxy CO2 Laser System K133915
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
July 21, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Cynosure. Incorporated dba Ellman Ms. Alison Sathe Director of Regulatory and Clinical Affairs 400 Karin Lane Hicksville, New York 11801
Re: K150587 Trade/Device Name: Cortex 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: June 15, 2015 Received: June 17, 2015
Dear Ms. Sathe:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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.
Sincerelv vours.
Joshua
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) K150587
Device Name Cortex Laser System
Indications for Use (Describe)
The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, 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 CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- · Laser skin resurfacing.
- · Treatment of furrows and wrinkles.
· Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- · Blepharoplasty.
- · Site preparation for hair transplants.
- · The fractional scanner is for skin resurfacing.
The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
| 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
510(K) Summary
This 510(K) Summary of safety and effectiveness for the Cortex Laser System is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Cynosure, Inc. dba Ellman |
|---|---|
| Address: | Cynosure, Inc. dba Ellman |
| 400 Karin Lane | |
| Hicksville, NY 11801 | |
| Contact Person: | Alison Sathe |
| Telephone/Email/Fax: | 513-658-8960 |
| asathe@ellman.com | |
| 516-267-6750 | |
| Preparation Date: | February 20, 2015 |
| Device Trade Name: | Cortex Laser System |
| Common Name: | CO2 Laser, Er:YAG Laser |
| Classification Name: | Instrument, Surgical, Powered, laser |
| 79-GEX, 21 CFR 878.4810 | |
| Legally Marketed Predicate | |
| Device(s): | Cortex Laser System K110897 |
| DEKA SmartXide2 Laser System K133895 | |
| C02-2B3 Galaxy CO2 Laser System K133915 |
Device Description:
The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
Intended Use:
The CO2 laser 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), gynecology, neurosurgery, orthopedics, 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.
4
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- Laser skin resurfacing.
- . Treatment of furrows and wrinkles.
- Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- Blepharoplasty. ●
- . Site preparation for hair transplants.
- The fractional scanner is for skin resurfacing. ●
The Er: Y AG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
Technological Characteristics:
| Cortex Laser System | |
|---|---|
| Source | CO2 |
| Wavelength | 10.6 micron (10,600nm) |
| Power to tissue | 0.5 - 40 W |
| Peak power | 200 W |
| Repetition Rate | 1 - 8 Hz / 240 Hz Super Pulse |
| Pulse Length | 0.1ms to 1 s |
| Laser operation modes | Continuous Wave, Blend (PW), Super Pulse |
| Aiming beam | 3mW (650nm diode) adjustable |
| Articulated arm | 7-joint articulated arm |
| Cooling type | Closed loop (liquid) |
| User Interface | LCD Touch Screen |
| Power input requirements | 110 - 120 VAC, 10 A, 50-60 Hz |
| Dimension (H x W x D) | 150 x 46 x 31 cm |
Performance Data: None submitted.
Substantial Equivalence:
4 The Er:YAG technical specifications of the Cortex Laser System are omitted as they remain unchanged and are not being compared to the predicate device.
5
The Cortex Laser System has the same intended uses and indications, technological characteristics, principles of operation as its predicate device. There are no new issues of safety or effectiveness. Thus, the Cortex Laser System is substantially equivalent to the predicate.