(134 days)
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications:
1064 nm wavelength
- . Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
- Removal or lightening of hair with or without adjuvant preparation. .
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.
The provided text is a 510(k) Summary for a medical laser system and does not contain information about a study comparing the device to acceptance criteria in the manner typically seen for AI/ML-based medical devices (e.g., performance metrics, expert reviews, ground truth establishment). Instead, this document focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics (especially those related to AI/ML product evaluation) cannot be extracted from this specific document.
Here's what can be extracted based on the provided text, and where gaps exist:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The "acceptance criteria" in this context are not quantitative performance thresholds in the way one might expect for an AI/ML diagnostic. Instead, they are met by demonstrating that the proposed device has the same intended use, technological characteristics, and performance characteristics as legally marketed predicate devices, thereby establishing it is "as safe, as effective, and performs as well as the predicate devices."
The study that proves the device meets "acceptance criteria" is essentially the substantial equivalence comparison presented in the document itself, rather than a separate clinical trial or technical performance study with a defined test set.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (vs. Predicates) |
|---|---|
| Intended Use Equivalence | Proposed device's intended use (Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis, plus specific wavelength indications for Tattoo Removal, Pigmented Lesions, Hair Removal, Skin Resurfacing, Benign Cutaneous Lesions, and Reduction of red pigmentation in hypertrophic and keloid scars) is deemed equivalent to predicate devices. Slight clarifications were made for pigmented lesions. |
| Technological Characteristics Equivalence | The proposed device and primary predicate device (K103118) have identical technological characteristics: Q-switched Nd:YAG laser, 1064nm/532nm wavelengths, 7-20 ns pulse duration, 1.6 J energy, 1-8 J/cm² fluence, 2-8.5mm spot sizes, 1-10 Hz repetition rate, and similar physical/electrical specifications. Other predicate devices have similar core technologies but with some variations in specific parameters (e.g., pulse duration, energy, fluence). |
| Performance Characteristics Equivalence | Implied by the identical/similar technological characteristics and intended uses. The document states: "The RevLite Q-Switched Nd:YAG Laser System is as safe, as effective, and performs as well as the predicate devices." No specific performance metrics (e.g., accuracy, sensitivity, specificity) for treating conditions are provided, as this is a device modification for clarification rather than a new performance claim. |
2. Sample size used for the test set and the data provenance
The document does not describe a test set, sample size, or data provenance because it's a 510(k) submission based on substantial equivalence to predicate devices, not on a new clinical performance study with a test cohort. The "study" here is primarily a comparison of specifications and intended uses with existing approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set or ground truth establishment relevant to an AI/ML context is mentioned.
4. Adjudication method for the test set
Not applicable. No test set or adjudication process is described.
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 is a laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laser system, not an AI-based algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this submission is established through the regulatory clearance of predicate devices, validating their safety and effectiveness for their stated intended uses and technological characteristics.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device with a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe an AI/ML device with a training set.
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.
·
510(k) Summary for RevLite Q-Switched Nd: YAG Laser System
A. Sponsor
Cynosure, Inc. 5 Carlisle Road Westford, MA 01886
B. Contact
C. Device Name
| Trade Name: | RevLite Q-Switched Nd: YAG Laser System |
|---|---|
| Common/usual Name: | Medical Laser System |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery |
| 21 CFR 878.4810, Class II |
D. Predicate Device
| Trade Name: | RevLite Q-Switched Nd:YAG Laser System |
|---|---|
| Common/usual Name: | Dermatology Laser System |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery21 CFR 878.4810, Class II |
| Premarket Notification: | HOYA PHOTONICS, Inc., K103118 (11/19/2010) |
| Trade Name: | SPECTRA Q-Switched Nd:YAG |
| Common/usual Name: | Laser System with Dye Handpieces |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery21 CFR 878.4810, Class II |
| Premarket Notification: | Lutronic Corporation, K113588 (2/2/2012) |
| Trade Name: | Palomar Q-YAG 5TM Nd:YAG Laser System |
| Common/usual Name: | Q: Switched Nd: YAG |
| Classification Name: | GEX-Powered laser surgical instrument, General & Plastic Surgery21 CFR 878.4810, Class II |
| Premarket Notification: | Palomar Medical Technologies, Inc., K061436 (12/06/2006) |
E. Device Description
The RevLite Q-Switched Nd: YAG Laser System consist of an electrically powered Console, in which laser energy produced within the system is delivered to the tissues by means of an articulated arm, Handpiece Adaptor and specially designed handpieces. The user ectivates laser emission by means of a footswitch.
F. Intended Use
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Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.
Specific Indications:
1064 nm wavelength
- . Tattoo Removal (dark ink: blue and black)
- Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, . Melasma and Cafe-au-lait
- Removal or lightening of hair with or without adjuvant preparation. .
- . Skin Resurfacing for Acne Scars and Wrinkles
- Benign cutaneous lesions; including, but not limited to: striae and scars (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dyc Laser Handpiece)
- Tattoo removal (light ink: red, sky blue, green) .
- Vascular Iesions including but not limited to: port wine birthmarks, telangiectasias, spider . angioma, cherry angioma, spider nevi
- Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar . lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis
- Skin Resurfacing for Acne Scars and Wrinkles .
- Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 650nm . wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral . part of the scar (excludes the 650nm wavelength)
The RevLite Q-Switched Nd: YAG Laser System (K103118) is currently indicated for the treatment of Dermal Pigmented lesions (1064 nm wavelength) and Epidermal Pigmentation lesions (532 nm wavelength). Both dermal and cpidermal pigmented lesions are types of benign pigmented lesions. Cynosure is seeking to clarify the indications for use statement for RevLite Q Switched laser to include examples of other pigmented lesions. There have been no changes to the device and the submission is only related to clarification of pigmented lesions.
G. Technological Characteristics
The laser systems have the same technological characteristics. All of the devices are Q-switched Nd: Y AG lasers operating at wavelengths of 1064 nm and 532 nm. Additionally, dye handpieces are available that convert the 532 nm wavelength beam into 585 nm or 650 nm wavelengths. The RevLite Q Switched Laser System has the exact same technological characteristics as the previously cleared RevLite Q Switched Laser System (K 103118). The clarified RevLite Indications for Use statement has the same example of benign cutaneous lesions, vascular lesions and epidermal pigmented treated as the RevLite, Spectra and Palomar predicates.
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| Proposed Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510(k)# | K103118 | K113588 | K061436 | |
| Manufacturer | Cynosure (HOYA ConBio) | Cynosure (HOYA ConBio) | Lutronic Corporation | Palomar MedicalTechnologies, Inc. |
| Device Name | RevLite Q-SwitchedNd: YAG Laser System | RevLite Q-SwitchedNd: YAG Laser System | Spectra Q-Switched Nd: YAGLaser system | Q-YAG 5 Nd: YAG lasersystem |
| Clearance Date | 11/19/2010 | 2/22/2012 | 12/6/2006 | |
| Classification/ Regulation | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) | 21 CFR 878.4810 (GEX) |
| Laser Medium | Nd: YAG | Nd: YAG | Nd: YAG | Nd: YAG |
| Operating Parameters | Q-Switched | Q-Switched | Q-Switched | Q-Switched |
| Wavelength | 1064nm / 532 nm | 1064nm / 532 nm | 1064nm / 532 nm | 1064nm / 532 nm |
| Pulse Characteristics: | ||||
| Maximum Pulse Duration | 7 - 20 ns | 7 - 20 ns | 5 - 10 ns | 3 ns |
| Energy Delivered | 1.6 J | 1.6 J | 1.2 J | 0.4 J |
| Fluence | 1 - 8 J/cm2 @ 3 - 8 mm spotsize | 1 - 8 J/cm2 @ 3 - 8 mm spotsize | 5 - 10 J/cm2 | 3.45 J/cm2 @ 4 mm spot size |
| Spot Sizes | 2-8.5mm range with 0.1mmincrements | 2-8.5mm range with 0.1mmincrements | 3,4,5,6,7,8 mm / 1,2,3,4,5,6,7mm (option) | 2 mm, 4 mm, 6 mm(optional) |
| Repetition Rate | Single shot, 1,2,5, 10 Hz | Single shot, 1,2,5, 10 Hz | Max. 10 Hz | 1-10 Hz |
| Physical Characteristics: | ||||
| System Dimensions | 31.8" (H) x 12" (W) x 28.5"(D) | 31.8" (H) x 12" (W) x 28.5"(D) | 11.6" (W) x 25.8" (L) x66.93" (H) | 18" (L) x 19" (H) x 17" (D) |
| System Weight | 131 lbs. | 131 lbs. | 194 lbs. | 88 lbs. |
| Electrical Requirements | AC 230 V, 50/60 Hz | AC 230 V, 50/60 Hz | AC 220-230V, 50/60 Hz | 100 - 240 V, 50/60 Hz |
| Maximum Power | 20W | 20W | 240MW | 4W |
:
・
ﺑ
Indications for Use Statement
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| Proposed Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 1064 nm wavelength | 1064 nm wavelength | 1064 nm Wavelength | 1064 nm Wavelength | |
| Tattoo Removal (dark ink:blue and black) | Tattoo Removal (dark ink:blue and black) | Tattoo removal: dark ink(black, blue and brown) | Indicated for skin resurfacingwith or without adjuvant | |
| Dermal Pigmented Lesions; | Dermal Pigmented Lesions | Removal of Nevus of Ota | preparation, dark ink tattoo | |
| including, but not limited to: | Nevus of Ota | Removal or lightening of | removal (e.g., black ink), | |
| Nevus of Ota, Lentigines, | Removal or lightening of hair | unwanted hair with or | removal of pigmented | |
| Nevi, Melasma and Cafe-au- | with or without adjuvant | without adjuvant preparation. | lesions, including, but not | |
| lait | preparation. | Treatment of Common Nevi | limited to, lentigines, nevi, | |
| Removal or lightening of | Skin Resurfacing for Acne | Skin resurfacing procedures | melasma, and cafe-au-lait, | |
| hair with or without adjuvant | Scars and Wrinkles | for the treatment of acne | and the removal or lightening | |
| preparation. | Benign cutaneous lesions, | scars and wrinkle | of hair. | |
| Skin Resurfacing for Acne | such as, but not limited to: | Treatment of melasma | ||
| Scars and Wrinkles | striae and scars | 532 nm Wavelength | ||
| Benign cutaneous lesions; | excludes the 650nm | 532nm Wavelength (nominal | Indicated for the removal of | |
| Intended Use / Indications forUse | including, but not limited to: | wavelength) | delivered energy of 585 nm | red ink tattoos, treatment of |
| striae and scars (excludes the | Reduction of red | and 650 nm with optional | vascular lesions, including | |
| 650nm wavelength) | pigmentation in hypertrophic | dye handpieces): | facial and leg veins, | |
| Reduction of red | and keloid scars where | Tattoo removal: light ink | telangiectasias, angiomas, | |
| pigmentation in hypertrophic | vascularity is an integral part | (red, tan, purple, orange, sky | hemangiomas, portwine | |
| and keloid scars where | of the scar (excludes the | blue, green) | stains, and most pigmented | |
| vascularity is an integral part | 650nm wavelength) | Removal of Epidermal | lesions (e.g., lentigines, | |
| of the scar (excludes the | Pigmented Lesions | ephelides). The 1064/532 nm | ||
| 650nm wavelength) | 532 nm wavelength (nominal | Removal of Minor Vascular | blended wavelength is | |
| delivered energy of 585 nm | Lesions including but not | indicated for tattoo removal. | ||
| 532 nm wavelength (nominal | and 650 nm with the | limited to telangiectasias | ||
| delivered energy of 585 nm | Optional Multilite Dye Laser | Treatment of Lentigines | ||
| and 650 nm with the | Handpiece) | Treatment of Cafe-Au-lait | ||
| Optional Multilite Dye Laser | Tattoo removal (light ink: red, | Treatment of Seborrheic | ||
| Handpiece) | sky blue, green) | Keratoses | ||
| Tattoo removal (light ink: | Vascular lesions including but | Treatment of Post | ||
| red, sky blue, green) | not limited to: port wine | Inflammatory Hyper | ||
| Vascular lesions including | birthmarks, telangiectasias, | Pigmentation | ||
| but not limited to: port wine | spider angioma, cherry | Treatment of Becker's Nevi, |
{4}------------------------------------------------
Indications for Use Statement
| Proposed Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|
| birthmarks, telangiectasias,spider angioma, cherryangioma, spider neviEpidermal Pigmentedlesions; including, but notlimited to: cafe-au-laitbirthmarks, solar lentiginos,senile lentiginos, Becker'snevi, Freckles, Nevus spilus,seborrheic keratosisSkin Resurfacing for AcneScars and WrinklesBenign cutaneous lesions;including, but not limited to:striae and scars (excludes the650nm wavelength)Reduction of redpigmentation in hypertrophicand keloid scars wherevascularity is an integral partof the scar (excludes the650nm wavelength) | angioma, spider neviEpidermal Pigmented lesionsincluding but not limited to:cafe-au-lait birthmarks, solarlentiginos, senile lentiginos,Becker's nevi, Freckles,Nevus spilusSkin Resurfacing for AcneScars and WrinklesBenign cutaneous lesions,such as, but not limited to:striae and scars (excludes the650nm wavelength)Reduction of redpigmentation in hypertrophicand keloid scars wherevascularity is an integral partof the scar (excludes the650nm wavelength) | Freckles and Nevi Spilus |
.
. . . . .
.
:
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H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated $10(k)s", the proposed device, RevLite Q-Switched Nd:YAG Laser System is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The RevLite Q-Switched Nd:YAG Laser System is as safe, as effective, and performs as well as the predicate devices.
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/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" arranged around the perimeter. Inside the circle is a stylized representation of three overlapping human figures.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2014
Cynosure Incorporated Mrs. Huda Yusuf, MSc. Senior Regulatory Affairs Specialist 5 Carlisle Road Westford, Massachusetts 01888
Re: K133254
Trade/Device Name: RevLife O-Switched Nd:YAG Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 4, 2013 Received: December 5, 2013
Dear Mrs. Yusuf:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{7}------------------------------------------------
Page 2 - Mr. Huda Yusuf, MSc.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) number | K133254 |
|---|---|
| Device Name | RevLite Q-Switched Nd:YAG Laser System |
| Intended Use | Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology,Dermatologic and General Surgical Procedures for Coagulation and Hemostasis |
| Specific Indications | 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines,Nevi, Melasma and Cafe-au-lait Removal or lightening of hair with or without adjuvant preparation. Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including, but not limited to: striae and scars (excludesthe 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity isan integral part of the scar (excludes the 650nm wavelength) 532 nm Wavelength (nominal delivered energy of 585 nm and 650 nm with the OptionalMultilite Dye Laser Handpiece) Tattoo removal (light ink: red, sky blue, green) Vascular lesions including but not limited to: port wine birthmarks, telangiectasias,spider angioma, cherry angioma, spider nevi Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks,solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheickeratosis Skin Resurfacing for Acne Scars and Wrinkles Benign cutaneous lesions; including, but not limited to: striae and scars, (excludesthe 650nm wavelength) Reduction of red pigmentation in hypertrophic and keloid scars where vascularity isan integral part of the scar (excludes the 650nm wavelength) |
| Prescription Use(Part 21 CFR 801 Subpart D) | Over-The-Counter UseAND/OR(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Felipe Aguel Date: 2014.03.05
11:44:57 -05'00'
(Division Sign-Off) for BSA Division of Surgical Devices 510(k) Number K133254
§ 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.