(77 days)
No
The description focuses on the laser technology and its components, with no mention of AI or ML capabilities. The determination of substantial equivalence is based on technical and functional characteristics compared to predicate devices, not on performance data that might be associated with AI/ML algorithms.
Yes
The device is intended for coagulation and hemostasis of vascular lesions, which are therapeutic medical interventions.
No
The device is described for "coagulation and hemostasis of vascular lesions," which are therapeutic surgical applications, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a laser console, fiber optic delivery system, handpiece, and handswitch/footswitch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For coagulation and hemostasis of vascular lesions." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The device is a laser system designed to deliver energy to tissue. This is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Acme Medical Nd:YAG Aesthetic Laser is a therapeutic medical device used for treating vascular lesions, not an in vitro diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Acme Medical Aesthetic Nd: YAG Laser is intended for dermatologic use. The 1064nm wavelength, long pulse duration, and large spot size of the Acme Medical Aesthetic Nd: YAG Laser allows for effective coagulation and hemostasis of vascular lesions. The laser system consists of a laser console and a delivery handpiece. The delivery handpiece is placed in contact with the target via a contact tip that is capable of cooling the epidermis. Clinical use of the device is indicated for clinical practitioners in plastic surgery and dermatology who have been technically trained on the use of the Acme Medical Aesthetic Nd: YAG Laser.
For coagulation and hemostasis of vascular lesions.
Product codes
GEX
Device Description
The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:
- a laser console; .
- internal computer; .
- control and display panel; .
- permanently attached fiber optic delivery system; .
- handswitch with the option of a footswitch; and .
- fiber optic coupled handpiece and tip with cooling capability. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical practitioners in plastic surgery and dermatology
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)
No performance data was submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical and functional characteristics between the Acme Medical Aesthetic Nd:YAG Laser and the predicate lasers and delivery systems. For this reason, performance data is not required.
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 Statement for the Acme Medical Nd:YAG Aesthetic Laser
General Information l.
Submitter: Acme Medical, Inc. 1181 Chess Drive, Suite B Foster City, CA 94404
Michael Levernier Contact Person:
Summary Preparation Date: 09 April 1999
II. Names
| Device Names: | Acme Medical Nd:YAG Aesthetic Laser |
|---|---|
| Primary Classification Name: | Laser Powered Surgical Instrument for use in Plastic |
| Surgery and Dermatology in accordance with 21 CFR 879- |
- 79-GEX |
III. Predicate Devices
The product specifications, functionality, indications for use, and treatment parameters of the Acme Medical Aesthetic Nd:YAG Laser are the same or very similar to the following legally marketed lasers:
IV. Product Description
The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of:
- a laser console; .
- internal computer; .
- control and display panel; .
- permanently attached fiber optic delivery system; .
- handswitch with the option of a footswitch; and .
- fiber optic coupled handpiece and tip with cooling capability. .
Revised page 000004 Revised April 28, 1999
1
510(k) Summary Statement 08 April 1999 Page 2.
V. Indications for Use
The Acme Medical Aesthetic Nd: YAG Laser is intended for dermatologic use. The 1064nm wavelength, long pulse duration, and large spot size of the Acme Medical Aesthetic Nd: YAG Laser allows for effective coagulation and hemostasis of vascular lesions. The laser system consists of a laser console and a delivery handpiece. The delivery handpiece is placed in contact with the target via a contact tip that is capable of cooling the epidermis. Clinical use of the device is indicated for clinical practitioners in plastic surgery and dermatology who have been technically trained on the use of the Acme Medical Aesthetic Nd: YAG Laser.
VI. Rationale for Substantial Equivalence
The Acme Medical Aesthetic Nd:YAG Laser shares the same indications for use, similar design features (including wavelength, active medium, cooling system, and controls), similar functional features (including pulse duration, and fluence), and similar treatment parameters of other marketed long pulsed Nd: YAG laser systems (as opposed to the Q-switched lasers). Therefore, the Acme Medical Aesthetic Nd:YAG Laser is substantially equivalent to the HGM VeinLase (K981952) and the ESC VascuLight DL (K980537).
VII. Safety and Effectiveness Information
No performance data was submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical and functional characteristics between the Acme Medical Aesthetic Nd:YAG Laser and the predicate lasers and delivery systems. For this reason, performance data is not required.
VIII.Conclusion
The Acme Medical Aesthetic Nd:YAG Laser system and delivery device was found to be substantially equivalent to similar currently marketed surgical laser devices for dermatologic applications. The Acme Medical Aesthetic Nd:YAG Laser shares identical indications for use, similar product specifications, and similar functional features as the currently marketed long pulsed, 1064nm wavelength Nd:YAG surgical lasers and their delivery devices.
Revised page 000005 Revised April 28, 1999
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three lines that resemble a person.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 28 1999
Mr. Michael Levernier Director, Regulatory/Clinical Affairs and Marketing Acme Medical, Inc. 1181 Chess Drive, Suite B Foster City, California 94404
K991234 Re:
Trade Name: Acme Medical Aesthetic Nd:YAG Laser Regulatory Class: II Product Code: GEX Dated: April 8, 1999 Received: April 12, 1999
Dear Mr. Levernier:
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 requirement, as set forth in the Quality System Regulation (QS) 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 - Mr. Michael Levernier
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,
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
Page 1 of 1
510(k) Number (if known):
Device Name: Acme Medical Aesthetic Nd:YAG Laser
Indications for Use:
For coagulation and hemostasis of vascular lesions.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
vision Sign-Off)
ical Restorative Devices 14991234
(Division (Division Sign-On)
Division of General Restoration 510(k) Number
(Optional Format 3-10-98)