(85 days)
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
a) LP1064nm
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The Alma Q laser system is also indicated for the treatment of wrinkles.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of pseudofolliculitis barbae (PFB).
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
- The intended use of the integral cooling system in the Alma O laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
b) OS 532nm
- Tattoo removal
-Red inks
-Blue and light blue inks
-Green inks - Treatment of benign vascular lesions
-Telangiectasias
-Spider angiomas
-Cherry angiomas
-Spider nevi - Treatment of benign pigmented lesions
-Cafe-au-lait birthmarks solar lentigines
-Solar lentigines
-Becker's nevi
-Freckles
-Nevus spilus
-Nevus of ota - Incision, excision, ablation, and vaporization of soft tissue in general dermatology
c) QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
The provided document is a 510(k) Premarket Notification for the Alma Q Laser, a medical device. This type of FDA submission seeks to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective.
The document does not include data from a study designed to prove the device meets specific performance acceptance criteria for clinical efficacy. Instead, it relies on a comparison to predicate devices and non-clinical performance testing to establish substantial equivalence. Therefore, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about expert-established ground truth or MRMC studies, as these types of studies were not deemed necessary for this particular submission.
Here's what the document states regarding performance and the justification for not conducting clinical studies:
- No Clinical Studies Deemed Needed: "Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no animal or clinical studies were deemed needed to support this submission." (Page 12)
- Reliance on Substantial Equivalence: The primary method for proving the device's safety and effectiveness is by demonstrating its substantial equivalence to previously cleared predicate devices (Mydon and Naturalase). The submission details the technological characteristics and indications for use of the Alma Q Laser and compares them to the predicate devices.
- Non-Clinical Performance Testing: "In all instances, the Alma Q Laser functioned as intended and the results observed were as expected." (Page 12). This refers to non-clinical performance testing, likely related to engineering specifications, safety standards, and functional verification, to ensure the device performs according to its design. The document lists several IEC standards that were likely used for this testing (e.g., IEC 60601-1 for electrical safety, IEC 60825-1 for laser safety).
In summary, this document does not contain the information required to populate a table of acceptance criteria and reported device performance from a clinical study, as no such clinical study was conducted or required for this 510(k) submission.
Therefore, I will reiterate the key points from the provided text that explain why no such study details are available:
- No Clinical/Animal Studies: The submission explicitly states that "no animal or clinical studies were deemed needed to support this submission" due to the device's similarities to predicate devices in safety and effectiveness profiles.
- Method of Proof: The method of proof for this device's safety and effectiveness is
Substantial Equivalenceto predicate devices. - Performance Testing: Refers to
Non-clinical performance testing(e.g., electrical safety, laser safety, software verification and validation, biocompatibility) which ensured the device functioned as intended and met expected results.
Because the request specifically asks for information that is not present in the provided text (i.e., acceptance criteria and performance from a clinical study), I cannot fulfill all parts of your request based solely on this document.
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Image /page/0/Picture/2 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" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a triple-line design representing the bodies.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2017
Alma Lasers LTD Rekha Anand Regulatory Associate Halamish St Pob 3021 Industrial Park Caesarea, 3088900 Il
Re: K170850
Trade/Device Name: Alma O 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: March 21, 2017 Received: March 22, 2017
Dear Rekha Anand:
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
{1}------------------------------------------------
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Alma O Laser
Indications for Use (Describe)
The Alma Q laser is intended for use in aesthetic and surgical applications requiring the ablation, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
a) LP1064nm
-
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
-
- The Alma Q laser system is also indicated for the treatment of wrinkles.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of 3. pseudofolliculitis barbae (PFB).
-
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
-
- The intended use of the integral cooling system in the Alma O laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
- b) OS 532nm
-
- Tattoo removal
- -Red inks
- -Blue and light blue inks
- -Green inks
-
- Treatment of benign vascular lesions
- -Telangiectasias
- -Spider angiomas
- -Cherry angiomas
- -Spider nevi
-
- Treatment of benign pigmented lesions
- -Cafe-au-lait birthmarks solar lentigines
- -Solar lentigines
- -Becker's nevi
- -Freckles
- -Nevus spilus
- -Nevus of ota
-
- Incision, excision, ablation, and vaporization of soft tissue in general dermatology
-
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c) QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 8 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Owner Name | Alma Lasers Inc. |
|---|---|
| Address | 485 Half Day Rd. Suite 100Buffalo Grove, IL 60089 |
| Contact Person | Kathy MaynorRegulatory ConsultantEmail : kathy.maynor@almalasers.comPhone: 352-586-3113 |
| Summary Preparation Date | March 21, 2017 |
I. Submitter Information [21 CFR 807.92(a) (1)]
II. Name of device [21 CFR 807.92 (a) (2)]
| Trade or Proprietary Name | Alma Q Laser | ||
|---|---|---|---|
| Common Device Name(s) andRegulatory Class | ProductCode(s) | Classification Panel | Regulation |
| Laser Powered SurgicalInstruments (& Accessories)Class II | GEX | General & PlasticSurgery Panel, 79 (SU) | § 878.4810, Laser surgicalinstrument for use in general andplastic surgery and dermatology |
| Surgical Powered Lasers and Delivery Devices/Hand pieceAccessories |
III. Predicate Devices [21 CFR 807.92(a) (3)]
| 510(k) # | Trade Name | Product Code |
|---|---|---|
| K040384 | Mydon/Quantel Derma | GEX |
| K032667 | Naturalase/Focus Medical | GEX |
| K992597 | Naturalase/Focus Medical | GEX |
IV. Device Description [21 CFR 807.92(a) (4)]
The subject device, Alma Q Laser incorporates a flash lamp pumped Nd:Yag laser. The radiation emitted by this device has the ideal 1064nm wavelength. It also incorporates a built-in frequency conversion technology to obtain the 532nm (green) wavelength. The laser system is operated with an articulated arm system for transmitting the laser radiation with different size tips. Alma Q can operate in Q-switching mode and produce 1064nm wavelength beam. This
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beam can also be efficiently converted into 532nm wavelength beam using a KTP crystal. This laser can also operate in long-pulsed mode at 1064nm wavelength. The system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas.
The material that could contact the patient during device use is aluminum with limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]
The Alma O laser is intended for use in aesthetic and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery.
The indications for use for the Alma Q laser share the same or similar indications for use as the predicate devices in that:
LP1064mm
- For the coagulation and hemostasis of benign vascular lesions such as, but not limited to, 1. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins.
- The Alma Q laser system is also indicated for the treatment of wrinkles. 2.
- The Alma Q is also indicated for the removal of unwanted hair and for the treatment of 3. pseudofolliculitis barbae (PFB).
-
- The Alma Q laser system is indicated for use on all skin types (Fitzpatrick IVI), including tanned skin.
- న. The intended use of the integral cooling system in the Alma Q laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
QS 532nm
- Tattoo removal -Red inks -Blue and light blue inks -Green inks
-
- Treatment of benign vascular lesions
- -Telangiectasias -Spider angiomas -Cherry angiomas
- -Spider nevi
-
- Treatment of benign pigmented lesions -Cafe-au-lait birthmarks -Solar lentigines -Becker's nevi -Freckles
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-Nevus spilus -Nevus of ota
-
- Incision, excision, ablation, and vaporization of soft tissue in general dermatology
QS 1064nm
The Alma Q laser treatment system is intended for use:
For the removal or lightening of unwanted facial or body hair.
For skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery,
Benign dermal pigmented lesions (dermal melanocytosis); and
For tattoo removal (dark and blue inks).
VI. Summary of technological characteristics of the device compared to the predicate[21 CFR 807.92(a)(6)]
The technological principles underlying the subject and the predicate devices are the same. A table comparing the key features of the subject and predicate devices is provided on the following page.
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| Characteristic | Alma Q | Mydon(K040384) |
|---|---|---|
| Wavelength | 1064nm | 1064nm |
| Output energy | 40J | 40J |
| Fluence | 10-450J/cm23.0mm spot = 30-300J/cm25mm spot = up to 240 J/cm27mm spot = 15-100 J/cm28mm collimated = up to 58J/cm2 | 10-450J/cm21.5mm spot = 160-450 J/cm23.0mm spot = 30-300J/cm25mm spot = up to 240 J/cm27mm spot = 15-100 J/cm210mm spot = 15-50 J/cm2 |
| Pulse duration | 0.5 - 60ms | 0.5 to 90 ms |
| Repetitionrate | 1,2,3, 5 for LP | Single shot to 10Hz |
| Deliverysystem | Removable tips | Permanently attached handpiece with inserts |
| Spot size | 3,5,7,8mm | 1.5-10mm |
| Aiming beam | red | red |
| Footswitch | Yes | Yes |
| Consoledimensions | 176 cm x 29 cm x 86 cm (topheight of articulated arm) (66.3"x 11.42" x 34") | Not known |
| Weight | 75 kg. / 165.4 lbs. | Not known |
| Indicationsfor Use | For the coagulation andhemostasis of benign vascularlesions such as, but not limitedto, port wine stains,hemangiomas, warts,telangiectasia, rosacea, venuslake, leg veins, and spider veins.2. The Alma Q laser system isalso indicated for the treatmentof wrinkles. 3. The Alma Q isalso indicated for the removal ofunwanted hair and for thetreatment of pseudofolliculitisbarbae (PFB). 4. The Alma Qlaser system is indicated for useon all skin types (FitzpatrickIVI), including tanned skin. 5.The intended use of the integralcooling system in the Alma Qlaser handpiece is to providecooling of the skin prior to lasertreatment, for the reduction ofpain during laser treatment, toallow for the use of higherfluences for laser treatmentssuch as hair removal andbenign vascular lesions, andto reduce the potential sideeffects of laser treatments. | For the coagulation and hemostasis of benignvascular lesions such as, but not limited to, portwine stains, hemangiomas, warts, telangiectasia,rosacea, venus lake, leg veins, and spider veins.2. The MYDON C laser system is also indicatedfor the treatment of wrinkles. 3. The MYDON Cis also indicated for the removal of unwanted hairand for the treatment of pseudofolliculitis barbae(PFB). 4. The MYDON C laser system isindicated for use on all skin types (FitzpatrickIVI), including tanned skin. 5. The intended useof the integral cooling system in the MYDON Claser handpiece is to provide cooling of the skinprior to laser treatment, for the reduction of painduring laser treatment, to allow for the use ofhigher fluences for laser treatments such as hairremoval and vascular lesions, and to reduce thepotential side effects of laser treatments. |
Alma Q LP 1064nm Substantial Equivalence Table
Premarket Notification, Traditional 510(k) Section 8: Page 4
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Alma Q QS 1064nm Substantial Equivalence Table
| Characteristic | Alma Q | Naturalase K992597 |
|---|---|---|
| Laserwavelength | QS 1064nm | QS 1064nm |
| Pulse width | 7ns | (6-8ns) |
| Light source | Solid state | Solid state |
| Repetition (Hz) | 1,2,5,10 Hz | 1,2,5,10 Hz |
| Max Outputenergy | 1800mJ | 1800mJ |
| Fluence | 2mm - 57.32 J/cm23mm - 25.5 J/cm24mm - 14.3 J/cm25mm - 9.17 J/cm26mm - 6.4 J/cm27mm - 4.7 J/cm28mm - 3.6 J/cm2 | 2mm - 57.32 J/cm23mm - 25.5 J/cm24mm - 14.3 J/cm25mm - 9.17 J/cm26mm - 6.4 J/cm27mm - 4.7 J/cm28mm - 3.6 J/cm29mm - NA10mm - NA |
| Spot Size | 3-7mm8mm collimated | 3 - 10mm |
| Operation mode | Single shot, continuous | Single shot |
| Aiming beam | Red. Variable intensity | red |
| Footswitch | Yes | Yes |
| Characteristic | Alma Q | Naturalase K992597 |
| Consoledimensions | 176 cm x 29 cm x 86 cm (topheight of articulated arm)(66.3" x 11.42" x 34") | 124cm x 43cm x 66cm(50"x17"x27") |
| Weight | 75 kg. / 165.4 lbs | 125Kg./275lbs. |
| Articulated arm | Yes | Yes |
| Electricalrequirements | 230 VAC, 13A, 50/60 Hz,single phase | AC 230 V, 50/60 Hz |
| Indications forUse | The Alma Q lasertreatment system isintended for use:For the removal or lighteningof unwanted facial or bodyhair.For skin resurfacing(ablation of epidermal skinlayers) in dermatology andaesthetic surgery,Dermal benign pigmentedlesions (dermalmelanocytosis); andFor tattoo removal (darkand blue inks). | The Lorad LT-100 lasertreatment system is intendedfor use:Alone or in conjunction withan adjuvant lotion for theremoval or lightening ofunwanted facial or body hair.One or two treatments may berequired for lightening orremoving unwanted hairwithout the adjuvant lotion;In combination with theadjuvant lotion for skinresurfacing (ablation ofepidermal skin layers) indermatology and aestheticsurgery,Dermal pigmented lesions(dermal melanocytosis);andFor tattoo removal (dark andblue inks).The adjuvant lotion is asuspension of carbon powderin a base of Light Mineral Oil,NF |
| Characteristic | Alma Q - Proposed | Naturalase K032667 |
| Laser | QS 532 | 532nm |
| wavelength | ||
| Pulse width | 7ns | (6-8ns) |
| Light source | Solid state | Solid state |
| Repetition (Hz) | 1,2,5,10 Hz | 1,2,5,10 Hz |
| Max Outputenergy | Single-Pulse:50-450mJDouble-Pulse:350-700mJ | 900 mJ |
| Fluence | 2mm - 22.3 J/cm23mm - 9.9 J/cm24mm - 5.6 J/cm25mm - 3.7J/cm26mm - 2.5 J/cm27mm - 1.8 J/cm28mm - 1.4 J/cm2 | 2mm - 28.66 J/cm23mm - 12.74 J/cm24mm - 7.17 J/cm25mm - 4.59 J/cm26mm - 3.18 J/cm27mm - 2.34 J/cm28mm - 1.79 J/cm29mm - NA |
| Spot Size | 2-7mm8mm collimated | 2mm-9mm |
| Operation mode | Single shot, double shot | Single shot |
| Aiming beam | Red, variable intensity | red |
| Footswitch | Yes | Yes |
| Articulated arm | Yes | Yes |
| Electrical | 230 VAC, 13A, 50/60 Hz,single phase | 220v, single phase, 8 amp |
| requirements | ||
| Console | 176 cm x 29 cm x 86 cm (topheight of articulated arm)(66.3" x 11.42" x 34") | 124cm x 43cm x 66cm(50" x 17" x 27") |
| dimensions | ||
| Weight | 75 kg. / 165.4 lbs. | 125Kg/275 lbs. |
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Alma Q QS532 Substantial Equivalence Table
{11}------------------------------------------------
| Indications for Use | ||
|---|---|---|
| Tattoo removal | Tattoo removal | |
| Red inks | Red inks (532 nm Hand Piece Adapter) | |
| Blue and light blue inks | Blue and light blue inks (Yellow Dye Pack) | |
| Green inks | Green inks (Red Dye Pack) | |
| Treatment of Benign Vascular | Treatment of Vascular Lesions - 532 nm | |
| Lesions Port wine birthmark | Hand Piece Accessory Port wine birthmark | |
| Telangiectasias | Telangiectasias | |
| Spider angiomas | Spider angiomas | |
| Cherry angiomas | Cherry angiomas | |
| Spider nevi | Spider nevi | |
| Treatment of Benign | Treatment of Pigmented Lesions - 532 nm | |
| Pigmented Lesions - | Hand Piece Accessory | |
| Cafe-au-lait birthmarks Solar | Cafe-au-lait birthmarks Solar lentigines | |
| lentigines | Solar lentigines | |
| Solar lentigines | Becker's nevi | |
| Becker's nevi | Freckles | |
| Freckles | Nevus spilus | |
| Nevus spilus | Nevus of ota | |
| Nevus of ota | ||
| Incision, excision, ablation, and vaporization | ||
| Incision, excision, ablation, | of soft tissue in general dermatology. | |
| and vaporization of soft tissue | ||
| in general dermatology | ||
VII. Performance Testing [21 CFR 807.92(b)(1)]
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for safety IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard: Usability
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1 Safety of laser products-Part 1: Equipment Classification, requirements and user's guide
IEC 62304 Medical device software - Software life cycle processes
In addition software verification and validation testing was performed and biocompatibility was established.
Premarket Notification, Traditional 510(k)
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In all instances, the Alma Q Laser functioned as intended and the results observed were as expected.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject and predicate devices, no animal or clinical studies were deemed needed to support this submission.
IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]
The Alma Q Laser is as safe and effective as the predicate devices Mydon and Naturalase (K040384, and K992597/K032667 respectively). The proposed subject device has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject and its predicate devices raise no new issues of safety or effectiveness. Thus, the Alma Q Laser is substantially equivalent.
§ 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.