(85 days)
Not Found
No
The summary describes a traditional surgical laser system with no mention of AI or ML capabilities, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as a surgical laser system intended for incision, excision, ablation, vaporization, and hemostasis of soft tissue, which are surgical procedures, not therapeutic ones in the typical sense of treating disease or promoting healing directly.
No
The device is described as a surgical laser system intended for "incision, excision, ablation, vaporization and hemostasis of soft tissue," which are all therapeutic, not diagnostic, actions.
No
The device description explicitly states it is a "surgical laser system" that produces laser energy and directs it through an "articulated arm system with removable handpieces," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Derma™ K laser system is for "incision, excision, ablation, vaporization and hemostasis of soft tissue." These are surgical procedures performed directly on the patient's body.
- Device Description: The device description confirms it's a "surgical laser system" that directs energy to "soft tissue."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
Therefore, the Derma™ K laser system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Derma™ K is drawn from that of the predicates Derma™ 20 and Topaz™ 30, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:
- · Dermatology
- · Cosmetic Surgery
- · Plastic and General Surgery
- · Dental and Oral Surgery
- · Gynecology
- · Orthopedic
- · Otorhinolaryngology (ENT)
- Podiatry
The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.
Product codes
GEX
Device Description
The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
None submitted.
Description of the test set, sample size, data source, and annotation protocol
None submitted.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None submitted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) Summary 4.
OCT 28 1997
Summary Page 1 of 2
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
-
Submitter's name, address, telephone, fax, & contact person 1 .
Dr. Zvi Ladin ESC Medical Systems Limited Title: Vice President, Clinical Applications and Regulatory Affairs Phone: 011-972-959-9000 Fax: 011-972-959-9050 Address: Yokneam Industrial Park, PO Box 240, Yokneam 20692, Israel -
- Date summary prepared:
July 31, 1997
- Date summary prepared:
-
- Product trade or proprietary name: Derma™ K laser system
-
- Product common name: Dual wavelength Er: YAG and CO2 Laser System
న్. Product classification name 21C.F.R. § 878.4810 Lasers in general and plastic surgery and in dermatology 21C.F.R. § 874.4500 Lasers for use in ENT 21C.F.R. § 884.4550 Gynecologic surgical laser
Legally marketed predicates device used for equivalency: 6.
ESC Topaz™ 30 Laser System (K965015)
ESC DermaTM 20 Laser System (K964253)
-
- Description:
The Derma™ K is a surgical laser system that produces laser (infrared) energy at wavelengths of 2.94 and 10.6 microns which is directed to soft tissue through an articulated arm system with removable handpieces.
- Description:
ESC Proprietary Information
1
Summary Page 2 of 2
-
- Statement of intended use:
The intended use of the Derma™ K is drawn from that of the predicates Derma™ 20 and Topaz™ 30, namely the vaporization, incision, excision, ablation, or photocoagulation of soft tissue in the listed surgical specialties of:
- Statement of intended use:
-
· Dermatology
-
· Cosmetic Surgery
-
· Plastic and General Surgery
-
· Dental and Oral Surgery
-
· Gynecology
-
· Orthopedic
-
· Otorhinolaryngology (ENT)
-
Podiatry
Clinical and Non-clinical Performance Data 9.
None submitted.
- Technological characteristics: 10.
The Er: YAG laser output characteristics of the Derma™ K system and the predicate Derma™ 20 system are identical in average power, increments of power available, and wavelength. The electronic control systems, safety systems, cooling systems, Er: YAG laser, and aiming beam diode laser are identical.
The CO2 laser output characteristics of the Derma™ K system and the predicate ESC Topaz™ 30 system are similar in average power, increments of power available, and wavelength. The laser and power source are identical in construction.
There are no technological characteristics of the Derma™ K that are different from the predicates.
Advisory: This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients or operators due to operator error or in high risk procedures.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 28 1997
Dr. Zvi Ladin Vice President, Clinical Applications and Regulatory Affairs ESC Medical Systems, Ltd. Yokneam Industrial Park, PO Box 240 Yokneam 20692, Israel
Re: K972872 Trade Name: DERMA™ K Laser System Regulatory Class: II Product Code: GEX Dated: July 31, 1997 Received: August 4, 1997
Dear Dr. Ladin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Dr. Zvi Ladin
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
toscella
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Derma™ K Laser System Device Name: ...
.
:
Indications For Use:
The Derma™ K laser system is intended for incision, excision, ablation, vaporization and hemostasis of soft tissuc.
(PLRASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
colly
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K972872 |
Prescription Use (Per 21 CFR 801.109)
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OR
Over-The-Counter Usc
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(Optional Format 1-2-96)