(90 days)
532nm Wavelength:
General Surgery: Coagulation, hemostasis, vaporization, excision, and incision of tissue. Photocoagulation of Vessels/Veins up to 1.5 mm
Endoscopic & Laparoscopic: Excising, Coagulation or Vaporization of tissue during Endoscopic or Laparoscopic procedures, Cholecystectomy and Appendectomy.
Gynecology: Ablation or lysis of intra-abdominal tissues via laparotomy or laparoscope. Ablation of endometrial implants, lysis of adhesions, ablation of the uterosacral ligaments, cutting/coagulating, treatment of uterine polyps and fibroids, salpingo-ophorolysis, and transection of uterine septa.
Laryngology: Photocoagulation or Vaporization of soft or fibrous tissue such as; hereditary hemorrhagic telangiectasia (vascular lesions), pigmented structures that are highly vascular, and tonsillectomy.
Otology: For; stapedotomy, stapedectomy, tympanoplasty with fascia graft, myringotomies, control of bleeding, removal of osseous disease of the external canal, removal of acoustic neuromas, lysis of adhesions and soft tissue adhesion, in both micro- and macro- otologic procedures.
Rhinology: For; control of epistaxis, turbinate reduction (excludes bone), treatment of endonasal polyps, hereditary hemorrhagic telangiectasia, synechia, hemangiomas, telangiectasia, vaporize of maxillary sinus cysts and polyps, treatment of papillomas and granulomas, endonasal dacryocystorhinostomy, treatment of lesions within the nose and sinus, creation of nasoantral window and coagulation of vessels or veins up to 1.5 mm in diameter.
Urology: Coagulation of veins or vessels up to 1.5 mm in diameter, management of condyloma acuminata, carcinoma in situ, small papillary bladder tumors, port wine stains, hemangioma of the external genitalia or bladder and urethral recanalization.
Neurosurgery: For; dorsal root entry zone lesions, spinal intramedullary tumor, medulloblastomas, acoustic neuromas, intracranial meningiomas, ventricular ependymomas, choroid plexus, carcinomas, hemangioblastomas, ependymoma extending into the brain stem, and intra- / extra- axial spinal cord tumors.
Ophthalmology: For; posterior and anterior treatment procedures including; diabetic retinopathy, retinal detachments, ablate tissues of the iris or trabeculum, peripheral iridectomy and iridotomy, trabeculoplasty, and senile macular degeneration. Other conditions of the retina in which the laser is deemed useful involving endophotocoagulation. Extraorbital procedures such as; coagulation of vessels or veins up to 1.5 mm in diameter, extra orbital pigmented or venous lesions; port wine hemangiomas or telangiectasia. Treatment for chronic dacryocystitis.
Dermatology: For; treating vascular lesions, dermatologic lesions, and/or cutaneous lesions such as; facial or extremities telangiectasias, venous anomalies, leg veins up to 1.5 mm in diameter, and port wine stains.
1064nm Wavelength:
General Surgery: For; incision or excision of all soft body tissues including; skin, subcutaneous and breast tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, internal organs and glands of the gastrointestinal, genitourinary, pulmonary, endocrine and exocrine systems, as well as cancers of theses systems. Treatment of larger and deeper vessels/veins up to 3.0 mm in diameter, 4.0 to 7.0 mm in depth.
ENT, Head & Neck: For; incision or excision of all soft body tissues including; skin, subcutaneous tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, organs and glands of the ENT system and access via endoscope, microscope or direct visualization.
Gastroenterology: For; esophageal neoplastic obstructions such as; squamous cell carcinoma, and adenocarcinoma, upper and lower GI bleeding such as; varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, stomach ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions and hereditary hemorrhagic telangiectasia. Papilliation of unresectable mucosal-based cancers, coagulation of arteriovenous malformations, ablation of; adenomatous polyps, benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Recanalization of obstructing lesions throughout the gastrointestinal tract, and endoscopic treatment of early oesophageal or gastric cancer.
Gynecology: For; endometrial ablation, treatment of menorrhagia, treatment of endometrotic implants, lysis of adhesions, treatment of cervical, vaginal, or vulvar dysplasia, and treatment of cervical, vaginal, or vulvar condyloma.
Neurology: For; treatment of arterio-venous malformations, and vascular intracranial tumors like meningiomas and metastatic spinal tumors.
Pulmonary: For; treatment of benign and malignant tracheobronchial lesions in the pulmonary airway including; squamous cell carcinoma, papillomas, adenocarcinoma, granulomas, and tracheal stenosis.
Urology: Treatment of superficial and invasive bladder carcinoma, urethral and ureteral strictures, benign or malignant lesions of the external genitalia, urethra and anus (condyloma acuminata), bladder neck contracture, and diverticulum.
Dermatology: Photocoagulation of vascular lesions for the reduction of lesion size. Treatment of vascular lesions such as; port wine stains (PWS), hemangiomas, angiomas, and venous anomilies. Incision/Excision of soft body tissues.
Otolaryngology: Bronchoscopy procedures such as; photocoagulation of endobronchial tumors.
The Combination Nd:YAG and Solid State, (Frequency Doubled Nd:YAG) Surgical Laser System is an instrument used in the application of photocoagulation of soft tissue using a 532nm wavelength. The system has the ability to use a 1064nm wavelength for applications including; Coagulation, Vaporization, and Cutting. The system can run both wavelengths in "Captured Pulse" which delivers high energy at very short pulse durations. The laser light is "pumped" by flashlamp technology.
The provided text is a 510(k) summary for a medical device called the "Combination Neodymium (Nd:)YAG and Solid State Green, Trade Name: Frequency Doubled Nd: Y AG Surgical Laser System" (Spectrum Veinlase).
Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a Class II medical device seeking substantial equivalence to legally marketed predicate devices. For such submissions, the FDA typically assesses equivalence based on technological characteristics and intended use rather than specific quantitative performance acceptance criteria from a clinical trial.
The document states that no nonclinical or clinical performance data was provided or required for this 510(k) submission. Therefore, there are no reported acceptance criteria or device performance metrics in the format of a table as typically seen for devices requiring clinical validation. The "reported device performance" is implicitly that it meets the "similar" characteristics to the predicates.
Instead, the submission argues substantial equivalence by comparing the Spectrum Veinlase's technological characteristics to several predicate devices. The "performance" is implicitly deemed equivalent if these characteristics are similar.
Technological Characteristics and Substantial Equivalence Comparison (Implicit "Performance"):
| Characteristic | Spectrum Veinlase (Submitted Device) | Predicate Devices (Examples given) | Comparison Description (Implicit Acceptance) |
|---|---|---|---|
| Wavelengths | 532nm, 1064nm (can run both in "Captured Pulse") | Coherent, VersaPulse: 532nm, 1064nm, 755nm Thermolase Softlight: 1064nm Laserscope Orion Series: 532/1064nm Cynosure PhotoGenica LPIR: 755nm (with 543nm aiming beam) | Similar wavelengths (specifically 532nm and 1064nm are present in both submitted and key predicates). |
| Energy Delivery | Photocoagulation of soft tissue (532nm), Coagulation, Vaporization, Cutting (1064nm), "Captured Pulse" (high energy, short pulse durations) | Coherent, VersaPulse: Q-switched (suggests pulsed delivery)Thermolase Softlight: Similar average power, pulses of equivalent durationLaserscope Orion Series: Pulsed power technology ("Starpulse" for high energy/short pulse) Cynosure PhotoGenica LPIR: Pulsed laser, similar pulse duration | Similar energy delivery mechanisms (pulsed power, average power, pulse durations). The "Captured Pulse" is compared to Laserscope's "Starpulse" for delivering high energy at short durations. |
| Indications for Use | Extensive list for both 532nm and 1064nm across various specialties (General Surgery, Gynecology, Dermatology, etc.) | Coherent, VersaPulse: Similar indications for use Thermolase Softlight: Hair removal & skin resurfacing (differs from Spectrum Veinlase, but same wavelength) Laserscope Orion Series: Treatment of dark ink tattoos (subset of Spectrum Veinlase's capabilities, but same 532/1064)Cynosure PhotoGenica LPIR: Treatment of leg veins 0.6mm-3.0mm (overlaps with Spectrum Veinlase's 532nm dermatology indications) | Similar indications for use in many areas, particularly with the 532nm wavelength (e.g., vascular lesions, leg veins) and 1064nm wavelength for general soft tissue applications and larger vessel treatments. The breadth of indications for the submitted device is broader than individual predicates, but specific applications are found in the predicate landscape. |
| Cooling System | Similar to predicates | Not explicitly detailed for predicates, but stated as a similarity in rationale | Assumed to be similar and adequate. |
| Control Systems | Interlock devices, displays (similar to predicates) | Not explicitly detailed for predicates, but stated as a similarity in rationale | Assumed to be similar in safety and user interface. |
| Spot Sizes / Areas | Similar to predicates | Similar treatment spots of equivalent diameter (for several predicates) | Similar spot sizes and treatment areas. |
| Beam Integrity | Similar to predicates | Not explicitly detailed for predicates, but stated as a similarity in rationale | Assumed to be similar. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No nonclinical or clinical performance data (test set data) was required or submitted for this 510(k). This was a substantial equivalence pathway based on technological characteristics.
- Data Provenance: Not applicable. No test data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment was needed for a test set, as no performance data was required/submitted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set was evaluated.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a laser surgical system, not an AI/imaging diagnostic device. No MRMC study was conducted or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser surgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no performance studies were conducted. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices based on their prior marketing clearance.
8. The sample size for the training set
- Not applicable. This device is a laser surgical system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
{0}------------------------------------------------
1 1998 SEP
K98/952
Instruments for Medicine and Diagnostics 3959 South 1820 West Salt Lake City, Utah 84104 (801) 972-0500 (801) 972-4884 (fax) William J McMahan,Ph.D., President Preparation Date: June 01, 1998
Summary of Safety and Effectiveness for the:
Combination Neodymium (Nd:)YAG and Solid State Green, Trade Name: Frequency Doubled Nd: Y AG Surgical Laser System.
Common Name: Spectrum Veinlase
Laser Instrument, Surgical Powered - 79GEX Classification Name:
Legally Marketed Predicate Devices for Substantial Equivalence:
Coherent, "VersaPulse" Nd: YAG Solid State Q - Switched.
Thermolase "Softlight" Nd: YAG Laser Hair Removal & Skin Resurfacing Laser.
Laserscope Orion Series Surgical Laser System.
Cynosure "PhotoGenica LPIR" Dermatologic Laser
Rationale for SE: The Spectrum Veinlase and Delivery Devices share similar indications for use, and similar design features including; wavelengths, beam integrity, cooling system, control systems such as interlock devices, and displays. Functional features such as; delivery power, pulse rates, energy type, spot sizes, and areas for treatment are also similar. The legally marketed devices include the above listed systems and their 510(k) number.
{1}------------------------------------------------
Description of Submitted Device:
The Combination Nd:YAG and Solid State, (Frequency Doubled Nd:YAG) Surgical Laser System is an instrument used in the application of photocoagulation of soft tissue using a 532nm wavelength. The system has the ability to use a 1064nm wavelength for applications including; Coagulation, Vaporization, and Cutting. The system can run both wavelengths in "Captured Pulse" which delivers high energy at very short pulse durations. The laser light is "pumped" by flashlamp technology.
Technological Characteristics and Substantial Equivalence:
The Coherent, VersaPulse uses O-switched frequency doubled, Q-switched Nd:YAG, and Q-switched Alexandrite: YAG laser energy to deliver 532nm, 1064nm and 755nm wavelengths. The VersaPulse delivers the same wavelength, similar average power, pulses of equivalent duration, and treatment spots of equivalent diameter. The indications for use are also similar.
TheThermolase Softlight Laser uses the identical wavelength. A Nd: YAG Rod, the output of which is 1064nm. The Softlight laser uses a carbon-based cream to aid in the removal of unwanted body hair and for skin resurfacing.Similar average power, pulses of equivalent duration, and treatment spots of equivalent diameter.
The Laserscope Orion Series Laser System offers the same 532/1064 capability and is capable of the pulsed power technology that we are offering.It is indicated in the treatment of dark ink tatoos. The laser delivers similar strength, similar average power, pulses of equivalent duration, and treatment spots of equivalent diameter. The "Starpulse" allows it to deliver high energy at short pulse durations.
The Cynosure PhotoGenica LPIR Laser uses a 755nm wavelength, obtained from a Flashlamp-Excited Solid State Pulsed Laser is indicated in the treatment of leg veins that are between 0.6 mm to 3.0 mm in size. The LPIR uses a HENE (CW) 543nm green aiming beam. Other areas of the PhotoGenica LPIR including; pulse duration, and treatment spots are equally similar.
{2}------------------------------------------------
treatment of leg veins that are between 0.6 mm to 3.0 mm in size. The LPIR uses a HENE (CW) 543nm green aiming beam. Other areas of the PhotoGenica LPIR including; pulse duration, and treatment spots are equally similar.
Nonclinical Performance Data:
None
Clinical Performance Data:
None
Conclusion:
The Combination Nd: YAG and Solid State Green (Frequency Doubled Nd: YAG) Surgical Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for the treatment of Indicated uses listed.
Additional Information:
None requested at this time.
{3}------------------------------------------------
Image /page/3/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three overlapping profiles suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1998 SEP
William J. McMahan, Ph.D. President Instruments for Medicine and Diagnostics 3959 West 1820 South Salt Lake City, Utah 84104
Re: K981952
Trade Name: Combination Neodymium (Nd:) Yag and Solid State Green, Frequency Doubled Nd: YAG Surgical Laser System Regulatory Class: II Product Code: GEX Dated: June 1, 1998 Received: June 3, 1998
Dear Dr. McMahan:
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 (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.
{4}------------------------------------------------
Page 2 - William J. McMahan, Ph.D.
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, PhD, M.D.
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
{5}------------------------------------------------
510(k) Number (if known): 上りしい ( 5)
Device Name:
Combination Nd:YAG and Solid State Green (Frequency Doubled Nd:YAG) Surgical Laser System
Indications For Use:
532nm Wavelength:
| General Surgery: | Coagulation, hemostasis, vaporization, excision, and incision oftissue. Photocoagulation of Vessels/Veins up to 1.5 mm |
|---|---|
| Endoscopic &Laparoscopic: | Excising, Coagulation or Vaporization of tissue duringEndoscopic or Laparoscopic procedures, Cholecystectomy andAppendectomy. |
| Gynecology: | Ablation or lysis of intra-abdominal tissues via laparotomy orlaparoscope. Ablation of endometrial implants, lysis of adhesions,ablation of the uterosacral ligaments, cutting/coagulating,treatment of uterine polyps and fibroids, salpingo-ophorolysis, andtransection of uterine septa. |
| Laryngology: | Photocoagulation or Vaporization of soft or fibrous tissue such as;hereditary hemorrhagic telangiectasia (vascular lesions), pigmentedstructures that are highly vascular, and tonsillectomy. |
| Otology: | For; stapedotomy, stapedectomy, tympanoplasty with fascia graft,myringotomies, control of bleeding, removal of osseous disease ofthe external canal, removal of acoustic neuromas, lysis of adhesionsand soft tissue adhesion, in both micro- and macro- otologicprocedures. |
| Rhinology: | For; control of epistaxis, turbinate reduction (excludes bone),treatment of endonasal polyps, hereditary hemorrhagictelangiectasia, synechia, hemangiomas, telangiectasia, vaporize ofmaxillary sinus cysts and polyps, treatment of papillomas andgranulomas, endonasal dacryocystorhinostomy, treatment of lesionswithin the nose and sinus, creation of nasoantral window andcoagulation of vessels or veins up to 1.5 mm in diameter. |
| Urology: | Coagulation of veins or vessels up to 1.5 mm in diameter,management of condyloma acuminata, carcinoma in situ, smallpapillary bladder tumors, port wine stains, hemangioma of theexternal genitalia or bladder and urethral recanalization. |
| Prescription Use(Per 21 CFR 801.109) | ORCounter Use |
| Indications for use, Spectrum Veinlase (Division Sign-Off) | Page 1 of 3Attachment "E" |
| Division of General Restorative DevicesK981952510(k) Number | |
| Neurosurgery: | For; dorsal root entry zone lesions, spinal intramedullary tumor,medulloblastomas, acoustic neuromas, intracranial meningiomas,ventricular ependymomas, choroid plexus, carcinomas,hemangioblastomas, ependymoma extending into the brain stem,and intra- / extra- axial spinal cord tumors. |
| Ophthalmology: | For; posterior and anterior treatment procedures including;diabetic retinopathy, retinal detachments, ablate tissues of the irisor trabeculum, peripheral iridectomy and iridotomy,trabeculoplasty, and senile macular degeneration. Other conditionsof the retina in which the laser is deemed useful involvingendophotocoagulation. Extraorbital procedures such as; coagulationof vessels or veins up to 1.5 mm in diameter, extra orbitalpigmented or venous lesions; port wine hemangiomas ortelangiectasia. Treatment for chronic dacryocystitis. |
| Dermatology: | For; treating vascular lesions, dermatologic lesions, and/orcutaneous lesions such as; facial or extremities telangiectasias,venous anomalies, leg veins up to 1.5 mm in diameter, and portwine stains. |
{6}------------------------------------------------
1064nm Wavelength:
| General Surgery: | For; incision or excision of all soft body tissues including; skin,subcutaneous and breast tissue, striated and smooth muscle, tendonand fascia, cartilage, mucous membrane, lymphatic tissue, internalorgans and glands of the gastrointestinal, genitourinary,pulmonary, endocrine and exocrine systems, as well as cancers oftheses systems. Treatment of larger and deeper vessels/veins up to3.0 mm in diameter, 4.0 to 7.0 mm in depth. |
|---|---|
| ENT, Head& Neck: | For; incision or excision of all soft body tissues including; skin,subcutaneous tissue, striated and smooth muscle, tendon and fascia,cartilage, mucous membrane, lymphatic tissue, organs and glandsof the ENT system and access via endoscope, microscope or direct |
For; esophageal neoplastic obstructions such as; squamous cell Gastroenterology: carcinoma, and adenocarcinoma, upper and lower GI bleeding such as; varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, stomach ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions and hereditary hemorrhagic telangiectasia. Papilliation of unresectable mucosal-based cancers, coagulation of arteriovenous malformations, ablation of; adenomatous polyps, benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Recanalization of obstructing lesions throughout the gastrointestinal tract, and endoscopic treatment of early oesophageal or gastric cancer.
visualization.
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
Page 2 of 3
Indications for use, Spectrum Veinlase (Division Sign-Off) Attachment "B"
Division of General Restorative Devices
510(k) Number K981952
{7}------------------------------------------------
| Gynecology: | For; endometrial ablation, treatment of menorrhagia, treatment ofendometrotic implants, lysis of adhesions, treatment of cervical,vaginal, or vulvar dysplasia, and treatment of cervical, vaginal, orvulvar condyloma. |
|---|---|
| Neurology: | For; treatment of arterio-venous malformations, and vascularintracranial tumors like meningiomas and metastatic spinal tumors. |
| Pulmonary: | For; treatment of benign and malignant tracheobronchial lesions inthe pulmonary airway including; squamous cell carcinoma,papillomas, adenocarcinoma, granulomas, and tracheal stenosis. |
| Urology: | Treatment of superficial and invasive bladder carcinoma, urethraland ureteral strictures, benign or malignant lesions of the externalgenitalia, urethra and anus (condyloma acuminata), bladder neckcontracture, and diverticulum. |
| Dermatology: | Photocoagulation of vascular lesions for the reduction of lesion size.Treatment of vascular lesions such as; port wine stains (PWS),hemangiomas, angiomas, and venous anomilies. Incision/Excision ofsoft body tissues. |
| Otolaryngology: | Bronchoscopy procedures such as; photocoagulation ofendobronchial tumors. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Wision of General Restorative Devices 51000 Number
Prescription Use
(Per 21 CFR 801.109)(
Indications for use, Spectrum Veinlase
ﺎ
§ 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.