(90 days)
Not Found
Not Found
No
The summary describes a laser device with specific physical parameters and mentions a clinical trial comparing it to other lasers. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes.
The device is used for skin resurfacing in the treatment of wrinkles, which is a therapeutic application.
No
The device is described as being used for "skin resurfacing in the treatment of wrinkles," which is a therapeutic rather than diagnostic function. It does not identify or characterize a disease or condition.
No
The device description explicitly details hardware components: a power supply, water cooling system, and optical bench, which are integral to the laser's function. 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 is "For skin resurfacing in the treatment of wrinkles." This is a therapeutic procedure performed directly on the patient's body (in vivo).
- Device Description: The device is a laser system designed to deliver energy to the skin. This is consistent with a therapeutic device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is to directly treat a condition on the skin.
N/A
Intended Use / Indications for Use
For skin resurfacing in the treatment of wrinkles
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second an a pulse energy of 2 Joules, the average power from the laser is 10 watts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
A clinical trial was conducted using a side by side comparison of the CB Erbium / 2.94 TM Er:YAG and a CO2 laser.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical trial was conducted using a side by side comparison of the CB Erbium / 2.94 TM Er:YAG and a CO2 laser. The reduction of wrinkles was comparable for both lasers with notably few side effects and faster recovery time with the CB Erbium / 2.94 TM Er:YAG Laser.
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.
Not Found
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
June 11, 1997
K970934
510(k) Summary
| Submitter: | Continuum Biomedical, Inc.
6533 Sierra Lane
Dublin, CA 94568 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Robert S. Anderson, Ph.D.
President |
| Date Summary Prepared: | March 13, 1997 |
| Device Trade Name: | CB Erbium / 2.94 TM Er:YAG Laser |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Schwartz Electro-Optics TriLase 2940
Coherent UltraPulse CO2 Laser |
| Device Description: | CB Erbium / 2.94 TM Er:YAG Laser consists of three interconnected
sections: the power supply, the water cooling system and the optical
bench. At 5 pulses per second an a pulse energy of 2 Joules, the
average power from the laser is 10 watts. |
| Intended Use: | For skin resurfacing in the treatment of wrinkles |
| Comparison: | CB Erbium / 2.94 TM Er:YAG Laser provides comparable results as
the CO2 laser for the treatment of wrinkles, with fewer side effects
and faster recovery time. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | A clinical trial was conducted using a side by side comparison of the
CB Erbium / 2.94 TM Er:YAG and a CO2 laser. The reduction of
wrinkles was comparable for both lasers with notably few side effects
and faster recovery time with the CB Erbium / 2.94 TM Er:YAG Laser. |
| Conclusion: | The CB Erbium / 2.94 TM Er:YAG Laser is another safe and effective
way to remove or reduce facial wrinkles. |
| Additional Information: | None requested at this time. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 1 1997
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Inc. 6533 Sierra Lane Dublin, California 94568
ધ્રકૃ Re:
K970934 Trade Name: CB Erbium 2.94TM Er: YAG Laser Regulatory Class: II Product Code: GEX Dated: March 13, 1997 Received: March 13, 1997
Dear Ms.Ridener:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
2
Page 2 - Ms. Laurie A. Ridener
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,
[signature]
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
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Page 1 of 1
970934
| 510(k) Number (if known): | pending |
|---|---|
| Device Name: | CB Erbium / 2.94 TM Er:YAG Laser |
| Indications for Use: | For skin resurfacing in the treatment of wrinkles |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970934
Prescription Use X OR Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)