(90 days)
954013, 970461, 014057
Not Found
No
The document describes a laser system for tissue treatment and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "coagulation, vaporization, ablation, or cutting of soft tissue (skin)", which describes a therapeutic action.
No
The device is described as a laser system intended for "coagulation, vaporization, ablation, or cutting of soft tissue (skin)," which are therapeutic procedures, not diagnostic ones. There is no mention of it providing information about a patient's health condition.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, and electronics, and a handpiece housing the laser. This is not a software-only 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 device is for "coagulation, vaporization, ablation, or cutting of soft tissue (skin)". This describes a therapeutic or surgical procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description details a laser system designed to deliver energy to tissue, consistent with the stated therapeutic uses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Cell Robotics, Inc. Ultra-Light laser system is a medical device intended for surgical procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
Product codes
GEX
Device Description
The Cell Robotics Ultra-Light Laser System is an Er: Y AG laser producing emission at a wavelength of 2940nm. The laser consists of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the handpiece, which houses the laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (skin)
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)
Nonclinical Performance Data: None Required
Clinical Performance Data: None Required
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Schwartz Electro-Optics TriLase2940, K# 954013, Cell Robotics Er: YAG Laser System, K# 970461, Asceplion-Meditec Dermastar Er: Y AG Laser System, K#014057
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
Attachment I
510(K) Summary Cell Robotics Ultra-Light Laser System
This 510(K) Summary of safety and effectiveness for the Cell Robotics Ultra-Light Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Cell Robotics, Inc. |
|---|---|
| Address: | 2715 Broadbent Parkway NE |
| Albuquerque, NM 87107 | |
| Contact Person: | Glen Goff, Manager of Regulatory Affairs |
| Telephone: | |
| Telefax: | (505) 343-1131 Ext. 124 |
| (505) 344-8112 | |
| Preparation Date: | 05/21/02 |
| Device Trade Name: | Cell Robotics Ultra-Light Laser System |
| Common Name: | Erbium:YAG laser device |
| Classification Name: | Instrument, Powered, Laser |
| 79-GEX | |
| 21 CFR 878-48 | |
| Legally Marketed Predicate | |
| Device: | Schwartz Electro-Optics TriLase2940, K# 954013 |
| Cell Robotics Er: YAG Laser System, K# 970461 | |
| Asceplion-Meditec Dermastar Er: Y AG Laser System, | |
| K#014057 | |
| Description of the Device | The Cell Robotics Ultra-Light Laser System is an Er: Y AG |
| laser producing emission at a wavelength of 2940nm. The | |
| laser consists of two interconnected sections: The cabinet | |
| which houses the power supply, the cooling system and | |
| the electronics, and; the umbilical cables and the | |
| handpiece, which houses the laser. | |
| Intended Use of the Device | The Cell Robotics, Inc. Ultra-Light Laser System is |
| intended for coagulation, vaporization, ablation, or cutting | |
| of soft tissue (skin) in dermatology, plastic surgery | |
| (including aesthetic surgery), oral surgery, and | |
| ophthamology. | |
| Nonclinical Performance | |
| Data: | None Required |
| Clinical Performance Data: | None Required |
| Conclusion: | The Cell Robotics Ultra-Light Laser System is |
| substantially equivalent to other existing legally marketed | |
| laser systems currently in commercial distribution. | |
| Additional Information: | None requested at this time |
1
:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a design that suggests forward movement or progress.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cell Robotics, Inc. Glen Goff Manager of Regulatory Affairs 2715 Broadbent Parkway, NE Albuquerque, New Mexico 87107
Re: K021946
Trade/Device Name: Cell Robotics Ultra-Light Laser System Regulation Number: 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 12, 2002 Received: June 13, 2002
Dear Mr. Goff:
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. Ilsting 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 (PMA), 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 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); 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.
3
Page 2 – Mr. Glen Goff
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
K 621946 510(k) Number: .
Device Name: Cell Robotics Ultra-Light Laser System
Indications for Use:
The Cell Robotics, Inc. Ultra-Light laser system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthamology.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styplurth
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K021946
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use