(175 days)
755 nm: The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.
1064 nm: The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I -VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm, respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.
The provided text is a 510(k) summary for the CLARITY II Laser System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria, ground truth, or statistical analysis typical for a de novo or PMA submission of an AI-powered diagnostic device.
Therefore, the specific information requested in the prompt about acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training is not present in this document. The device in question is a laser system for dermatological treatments, not an AI diagnostic tool.
However, I can extract the information that is available and clarify what is missing based on your prompt.
Summary of Device Performance and Equivalence
The CLARITY II Laser System is being submitted as substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate device, or if there are differences, they do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Type of Acceptance Criteria (Not Explicitly Stated as AC, but as basis for SE) | CLARITY II Laser System Performance (Reported as technological characteristics similar to predicates) | Predicate Device 1: CLARITY LPC (K130199) | Predicate Device 2: Elite + (K141425) |
|---|---|---|---|---|
| 755 nm | - Max Fluence (J/cm²) | 600 | 600 | 60 |
| - Max Energy (J) | 60 | 60 | 30 | |
| - Max Rep Rate (Hz) | 10 | 10 | 5 | |
| - Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| - Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18,20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 | |
| 1064 nm | - Max Fluence (J/cm²) | 600 | 600 | 300 |
| - Max Energy (J) | 100 | 100 | 50 | |
| - Max Rep Rate (Hz) | 10 | 10 | 10 | |
| - Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| - Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18,20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 | |
| Common Features | - Aiming Beam | Green | Green | Red |
| - Electrical Requirements | AC220-230V 50/60 Hz; Fuse: 250V/30A, Circuit Breaker: 30A; Power Consumption: 6.0 kVa | VAC 220-230, single phase, 30A, 50/60 Hz | VAC 208/240, single phase, 30A, 50/60 Hz | |
| - Size (mm) | 563.6 (W) x 952.3 (L) x 998.5 (H) mm | 434 (W) x 776.8 (D) x 1148.8 (H) | 381 (W) x 635 (D) x 1041.4 (H) | |
| - Weight (kg) | 110 | 110 | 81.8 | |
| - Optical Delivery System | Optical fiber with handpiece | Optical fiber with handpiece | Optical fiber with handpiece | |
| - Cooling System | Chilled Air or ICD | Chilled Air or ICD | Chilled Air | |
| Distinguishing Features | - Skin temperature monitoring | Included (informational only) | Not specified | Not specified |
| - Intelligent Tracking Tip | Included (ensures selectable overlap) | Not specified | Not specified |
Note: The "acceptance criteria" here are inferred to be the characteristics of the predicate devices which the CLARITY II aims to match or demonstrate non-significant difference from, to achieve substantial equivalence. No explicit performance metrics or thresholds are stated as "acceptance criteria."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The submission states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This indicates that no new clinical study with a test set was conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. No clinical test set or ground truth determination is described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No clinical test set or adjudication method 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 / Not Provided. This device is a laser system and not an AI diagnostic tool that would typically undergo an MRMC study related to human reader performance with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This device is a physical laser system, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No clinical ground truth determination is described as no new clinical studies were submitted.
8. The sample size for the training set
- Not Applicable / Not Provided. This submission does not describe a training set as it's not an AI/ML algorithm submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As no training set is described, no ground truth establishment for it is mentioned.
Additional Information from the Document:
- Bench Testing: The device complies with applicable standards: ISO 13485:2016, ISO 60601-1 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility). These are considered part of the performance data to demonstrate safety and effectiveness for substantial equivalence.
- Clinical Testing: The document explicitly states: "No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness." This means the submission relies on the established safety and effectiveness of the predicate devices.
- Differences from Predicates: The CLARITY II includes a skin temperature monitoring feature (for informational purposes only) and an Intelligent Tracking Tip (ensures selectable overlap of contiguous pulses). The submission argues these differences "do not affect the safety and effectiveness of the subject device."
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Lutronic Corporation James Childs Clinical Science Director Lutronic Center, 219, Sowon-ro Deogyang-gu. Goyang-si, 410-220 Republic of Korea
June 14, 2019
Re: K183566
Trade/Device Name: CLARITY II 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: May 8, 2019 Received: May 13, 2019
Dear James Childs:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R.P. Ogden, MS Acting Assistant Director, Light Based Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183566
Device Name
Clarity II Laser System
Indications for Use (Describe) 755 nm
The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick 1-VI) including tanned skin.
The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.
1064 nm
The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I - VI, including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques.
The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | ||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
6. 510(k) Summary
The Company's 510(k) Summary for the CLARITY II Laser System is as follows:
510(k) Summary for the Lutronic Corporation CLARITY II Laser System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Applicant:
Lutronic Corporation 219, Sowon-ro Haengsin-dong, Deogyang-gu. Goyang-si, Gyeonggi-do, 410-722
Republic of Korea Tel: (82) 31-908-3440 Fax: (82) 31-907-3440
Contact Person:
Mark W. Sheehan Regulatory Affairs Specialist Lutronic Global 19 Fortune Drive Billerica, MA 01821 Tel: (888) 588-7644 ext. 6253
Summary/Preparation Date: December 20, 2018
2. Names
Trade Name:
CLARITY II Laser System
Common Name:
Classification Name:
Dermatology Laser
Laser instrument, Surgical powered
Product Code: GEX Panel: General and Plastic Surgery
3. Predicate Devices
The CLARITY II Laser System is substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425).
4. Device Description
The CLARITY II Laser System contains two separate resonators, an Alexandrite resonator and an Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelength 755 nm and 1064 nm,
{4}------------------------------------------------
respectively. The outputs of each laser generator and the aiming beam are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 755 nm or 1064 nm wavelength. It is a medical device, designed for specific clinical applications, emitting laser energy via a handpiece and controlled by the user with a handpiece finger switch or optional footswitch. The CLARITY II Laser System consists of a system main body with an LCD touch screen, optical fiber with an AC or ICD handpiece.
The control panel is equipped with an LCD touch screen so that users may easily adjust parameters for optimal settings.
The CLARITY II Laser System is a medical device, designed for specific clinical applications, emitting laser energy at 755 nm and 1064 nm via a handpiece attached to an optical fiber. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in very rapid highly localized temperature increase in the target.
The CLARITY II Laser System is composed of three main components, including the system main body, optical fiber (with optional AC handpiece or ICD handpiece), and the footswitch. The system main body is composed of the system control module, power supply, laser module, control panel (LCD touch screen), emergency stop button, and key switch. Laser radiation will be emitted from the handpiece through the optical fiber when the footswitch or finger switch is pressed. Safety goggles are provided with the system (optical density of 7 or higher at 1064 nm and 755 nm) for ancillary personnel. The casters and handle on the main body allows for transportation of the laser system within the treatment room. The laser console measures 563.6 mm (W) x 952.3 mm (L) x 998.5 mm (H).
The laser delivery system begins at the laser aperture, which is the fiber socket, at the upper front of the device. At this point, the invisible and infrared laser beam (755 nm or 1064 nm) and the visible 515-535 nm aiming beam are fed into and pass through the optical fiber and exit at the handpiece aperture.
Cartridges are available for the AC handpiece and ICD handpiece. The system is fitted with a window to protect the lens inside the cartridges from foreign material. The cartridge irradiation diameters available within the system are 2, 3, 5, 8, 10, 12, 15, 16, 18, 20, 22, 24mm. Users can use a cartridge fitted with an intelligent tracking tip (roller), O-type tip, C-type tip, or I-type tip.
The AC handpiece can be used with the CryoMini air cooling system that was cleared April 2008 (K080735).
{5}------------------------------------------------
5. Indications for Use
755 nm
The CLARITY II 755 nm Laser System is indicated for temporary hair reduction and stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime on all skin types (Fitzpatrick 1-VI) including tanned skin. The 755 nm laser is also indicated for treatment of benign pigmented lesions, vascular lesions and wrinkles.
1064 nm
The CLARITY II 1064 nm Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I -VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The 1064 nm laser is also indicated for coagulation and hemostasis of soft tissue, for hemostasis of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 nm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
6. Substantial Equivalence
The CLARITY II Laser System is substantially equivalent to the CLARITY LPC Laser System (K130199) and the Elite + Laser (K141425). It has the same technological characteristics as the predicate devices. All three devices use two separate laser resonators, an Alexandrite resonator and an Nd: Y AG (Neodymiumdoped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 755 nm and 1064 nm. They have the same intended uses and similar operating principles. They also have the same spot sizes, pulse widths and fluences. The laser systems differ in the features offered. Unlike its predicated devices, the Subiect device includes a skin temperature monitoring feature for informational purposes only. In addition, the Subject device includes an Intelligent Tracking Tip that insures selectable overlap of contiguous pulses during treatment. These features, however, do not affect the safety and effectiveness of the subject device and therefore it is substantially equivalent to the Predicate devices.
{6}------------------------------------------------
7. Performance Data
The Company's performance data for the CLARITY II Laser System is as follows:
| Device Name | Clarity II | Clarity LPC | Elite + | |
|---|---|---|---|---|
| Manufacturer | Lutronic Corporation | LutronicCorporation | Cynosure | |
| 510(k) Number | NA | K130199 | K141425 | |
| Max Fluence(J/cm²) | 600 | 600 | 60 | |
| Max Energy (J) | 60 | 60 | 30 | |
| 755 nm | Max Rep Rate (Hz) | 10 | 10 | 5 |
| Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18,20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 | |
| Max Fluence (J/cm²) | 600 | 600 | 300 | |
| Max Energy (J) | 100 | 100 | 50 | |
| Max Rep Rate (Hz) | 10 | 10 | 10 | |
| Pulse Duration (ms) | 0.1 - 300 | 0.35 - 300 | 0.1 - 300 | |
| 1064 nm | Spot Sizes (mm) | 2,3,5,8,10,12,15,16,18.20,22,24 | 2,3,5,8,10,12,15,18,20 | 3,5,7,10,12,15,18,20,22,24 |
| Aiming Beam | Green | Green | Red | |
| 755/1064nm | ElectricalRequirements(Powerconsumption) | AC220-230V 50/60 HzFuse: 250V/30A, CircuitBreaker: 30APower Consumption: 6.0kVa | VAC 220-230, singlephase, 30A, 50/60 Hz | VAC 208/240, singlephase, 30A, 50/60 Hz |
| Size (mm) | 563.6 (W) x 952.3 (L) x998.5 (H) mm | 434 (W) x 776.8 (D)x 1148.8 (H) | 381 (W) x 635 (D) x1041.4 (H) | |
| Weight (kg) | 110 | 110 | 81.8 | |
| Optical DeliverySystem | Optical fiber withhandpiece | Optical fiber withhandpiece | Optical fiber withhandpiece | |
| Cooling System | Chilled Air or ICD | Chilled Air or ICD | Chilled Air |
Bench Testing
The CLARITY II Laser System complies with all applicable standards, including ISO 13485:2016, ISO 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility.
Clinical Testing
No performance data has been provided since the CLARITY II Laser System is equivalent to the previously cleared predicate devices with no new issues regarding safety and effectiveness.
8. Conclusion
The intended use of the CLARITY II Laser System is virtually identical to the intended use of the predicate devices and the technological characteristics of the CLARITY II Laser System. Any differences between the CLARITY II Laser System and the predicate devices have no
{7}------------------------------------------------
significant influence on safety or effectiveness of the CLARITY II Laser System. Therefore, the CLARITY II Laser System is substantially equivalent to the predicate devices.
§ 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.