(134 days)
Not Found
No
The document describes a laser system for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is used in surgical applications for the excision, incision, ablation, vaporization, and coagulation of soft tissue, which directly involves treatment of diseases or injuries.
No
The device is a laser system designed for surgical applications, specifically for cutting and ablating soft tissue, and skin resurfacing. Its intended use is therapeutic, not diagnostic.
No
The device description explicitly lists multiple hardware components including a laser console, articulated arm, handpiece, control/display panel, finger trigger/foot pedal, laser head, CPU control system, power supply, and internal cooling system. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the Erbium 2000 laser family is designed for surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. These are procedures performed directly on the patient's body (in vivo).
- Intended Use: The intended use is for surgical procedures across various specialties, not for analyzing biological samples.
The device is a surgical laser, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
Phantom Erbium lasers are composed of the following components: - a laser console . - a counterbalanced articulated arm and handpiece . - a control / display panel ● - a finger trigger or foot petal control ● - ● a laser head w / beam optics - a CPU control system - . a power supply - an internal cooling system Models range from 5 to 50 Watts average power.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands
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)
Not Found
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.
K904627, K905802, K954013, K960032, K961748, K964128, K962902, K964016, K964532, K963339, K951812, K912029
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
DEC 1 9 1997
510(k) Summary Statement
| Applicant: | Phantom Technologies, Inc.
845 Commercial Avenue
Palo Alto, California 94303 | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Nations
Phone: 415-493-9155
Fax: 415-493-9146 | |
| Device Name: | Erbium 2000
Model A
Model B
Model C
Model D
Model E | |
| Class of the device and panel: | Class II
Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 | |
| Performance Standards: | UL544, UL2601.1, IEC601.1, IEC825
21 CFR 1040.10 & 1040.11 | |
| Reason for submission: | New laser system family with
substantial equivalence. | |
| Predicate Devices: | Pfizer
Pfizer
Schwartz Electro Optics
Coherent
Continuum Biomedical
Aesculap-Meditec
HGM
Fotana/Candela
Laserscope
ESC Medical
Coherent
Coherent
Coherent
Laserscope | K904627
K905802
K954013
K960032
K961748
K964128
Unknown
K962902
K964016
K964532
K963339
K951812
K912029
Unknown |
Device Description:
1
Phantom Erbium lasers are composed of the following components:
- a laser console .
- a counterbalanced articulated arm and handpiece .
- a control / display panel ●
- a finger trigger or foot petal control ●
- ● a laser head w / beam optics
- a CPU control system
- . a power supply
- an internal cooling system
Models range from 5 to 50 Watts average power.
Indications For Use:
The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
2
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 an abstract symbol that resembles a stylized eagle or bird in flight, with the negative space forming a human profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 19 1997
Mr. James A. Nations Director, Regulatory Affairs Phantom Technologies, Incorporated 845 Commerical Avenue Palo Alto, California 94303
Re: K972915
Trade Name: Erbium 2000 Laser Family, Models A, B, C, D, and E Regulatory Class: II Product Code: GEX Dated: November 13, 1997 Received: November 19, 1997
Dear Mr. Nations:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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. Nations
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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,
focollpe
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 I of of i
510(k) Number (if known):_K972915
Device Name: ERBIUM 2000 LASER FAMILY
Indications For Use:
The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
(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 | K972915 |
| Prescription Use | X | OR | Over-The-Counter Use | ____________________ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |