(90 days)
No
The summary describes a laser device for soft tissue procedures and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The "Intended Use / Indications for Use" states "coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing," which are therapeutic actions.
No
The device is described as a laser intended for various surgical procedures (coagulation, ablation, vaporization, or cutting of soft tissue), which are therapeutic, not diagnostic.
No
The device description explicitly states it is an "erbium:YAG laser," which is a hardware component that emits energy. The intended use also describes a physical interaction with tissue (coagulation, ablation, vaporization, cutting), which is performed by the laser hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The device description confirms it's a laser that emits energy, consistent with a surgical or therapeutic device, not a diagnostic one.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or assays.
Therefore, based on the provided information, the Er:aser™ laser is a therapeutic/surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Epulse laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.
The Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.
Product codes
GEX
Device Description
The Epulse laser is an erbium:YAG laser which emits its energy at 2.94 um. See below for additional specifications.
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
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)
None. The specifications and intended uses of the Epulse laser are the same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use.
Because of this, performance data were 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
长973576 DEC - 9 1997
ATTACHMENT A
.. .. ...
....... :
510(k) SUMMARY
Epulse Er:aser™ Laser System
This 510(k) summary of safety and effectiveness for the Epulse Ernaser™ Laser System is a This 510(k) summary of salery and crecuirements of SMDA 1990 and follows Office of submitted in accordance with the requirements of the organization and content of a 510(k) summary.
| Applicant: | Epulse Technologies, Inc. |
|---|---|
| Address: | 4838 Bentree Avenue |
| Long Beach, CA 90807-1007 | |
| Contact Person: | Mr. Sanford Damasco |
| VP Engineering and Chief Operating Officer | |
| 4838 Bentree Avenue | |
| Long Beach, CA 90807-1007 | |
| Telephone: | 562-984-7729 |
| 562-984-0788 (Fax) | |
| Preparation Date: | |
| (of the Summary) | August 1997 |
| Device Trade Name: | Er:aser™ Laser System (Epulse Laser System) |
| Common Name: | Erbium: Yttrium, Aluminum; Garnet (Er:YAG) |
| Laser System; Erbium Laser | |
| Classification | |
| Name: | Laser surgical instrument for use in general and plastic surgery and in |
| dermatology (see: 21 CFR 878.4810). | |
| Product Code: | GEX; Panel 79. |
| Legally marketed | |
| predicate devices | Schwartz Electro-Optics, Inc., TriLase 2940 Erbium Laser, |
| and Continuum Biomed, Inc., Multilite Erbium Laser System | |
| Description of | |
| the Device | The Epulse laser is an erbium:YAG laser which emits its energy at |
| 2.94 um. See below for additional specifications. | |
| Intended Use of the | |
| Epulse laser: | The Epulse laser is intended for coagulation, vaporization, ablation, or |
| cutting of soft tissue in dermatology and plastic surgery, including | |
| aesthetic surgery and skin resurfacing. |
1
This intended use is the same or similar to that for the claimed predicate devices.
The SEO Medical TriLase 2940 is indicated for use in small and large TriLase Laser: joint Arthroscopy, including microdiscectomies, endoscopic procedures and general surgical procedures for cutting (incision/excision), vaporizing and coagulating soft tissues. All soft tissues encountered in surgical procedures are included in this indication, such as, but not limited to, skin, subcutaneous tissue, striated and smooth tissue, muscle, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties include dermatology, plastic surgery (emphasis added), general surgery, urology, gynecology, pulmonary surgery, gastroenterology, ENT, thoracic-surgery, oral & maxillofacial surgery, ophthalmology, and podiatry.
The Multilite laser information includes "Cosmetic laser surgery ... [is] Multilite Laser: primarily restricted to applications in dermatology, plastic surgery, and aesthetic surgery." (emphasis added)
None. The specifications and intended uses of the Epulse laser are the Performance Data: same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use.
Because of this, performance data were not required.
- CONCLUSION: The Epulse laser is substantially equivalent to legally marketed predicate devices, i.e., the Schwartz Electro-Optics, Inc. TriLase 2940 erbium laser (K954013) and the Continuum Biomed, Inc. Multilite - erbium laser system (K961748).
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1997
Mr. Sanford Damasco VP Engineering and Chief Operating Officer Epulse Technologies, Inc. 4838 Bentree Avenue Long Beach, California 90807-1007
Re: K973576
Trade Name: Epulse Model 2940 Er:aser™ Er:YAG Laser System Regulatory Class: II Product Code: GEX Dated: September 2, 1997 Received: September 19, 1997
Dear Mr. Damasco:
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 - Mr. Sanford Damasco
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,
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
4
ATTACHMENT D
510(K) Number: K923576
Epulse Erbium Laser System (Er:aser™) Device Name:
Indications For Use:
The Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
11
Prescription Use Per 21 CFR 810.100)
OR
Over-The/Counter-Use
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K9 73576,