Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment 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 I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles
The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

Indications in Dermatology and Aesthetics:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned thair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6.9 and 12 months after the completion of a treament regime.
Treatment of wrinkles.
Treatment of wrinkles with S11 (LX Runner) scanner.
Treatment of mild to moderate inflammatory acne vulgaris.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,
hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including:
Matrixectomy
Radical nail excision
Periungual and subungual warts
Plantar warts
Neuromas
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophylla rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

NNd:YAG laser (1064 nm wavelength) therapy:

Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

Device Description

The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamppumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).

AI/ML Overview

The provided text is a 510(k) summary for the Fotona AvalancheLase Family device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical characteristics and indications for use. It does not include a description of acceptance criteria for a device performance study or the study that proves the device meets those criteria in the way typically associated with AI/ML device evaluations.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI assistance effect size, standalone performance, training set details) are not applicable as this document describes a traditional laser surgical instrument undergoing a 510(k) clearance, not an AI/ML powered device.

However, I can extract the information that is present concerning performance claims and the basis for substantial equivalence.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in the formal sense for performance metrics like sensitivity, specificity, accuracy, etc., as it's not an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to recognized standards. The "performance" is implicitly considered to be comparable to the predicate devices if the technical characteristics are similar and the device meets safety standards.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (AvalancheLase Family)
Wavelength (match predicate)	Alexandrite: 755 nm; Nd:YAG: 1064 nm
Laser Media (match predicate)	Alexandrite: Flashlamp solid state Alexandrite rod; Nd:YAG: Flashlamp solid state Nd:YAG rod
Aiming Beam (comparable to predicate)	520 nm
Output Mode (match predicate)	Pulsed
Fluence (Up to comparable levels of predicate)	Alexandrite: Up to 500 J/cm²; Nd:YAG: Up to 600 J/cm²
Spot Size (comparable to predicate)	2-30 mm
Pulse Width (comparable to predicate)	Alexandrite: 0.2 – 200 ms; Nd:YAG: 0.1 - 200 ms
Repetition Rate (comparable to predicate)	Alexandrite: Up to 60 Hz; Nd:YAG: Up to 80 Hz
Beam Delivery (match predicate)	Fiber
System Cooling (match predicate)	Self-contained, water to air heat exchanger
User Interface (match predicate)	LCD Touchscreen
Safety and Electrical Standards (conformity)	Conforms to multiple IEC/AAMI/ISO standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971)
Software Verification/Validation (according to FDA guidance)	Completed (considered "moderate" level of concern)
Biocompatibility (according to ISO 10993-1)	Performed on handpieces and scanner for direct contact components
Indications for Use (comparable to predicate without new safety/effectiveness questions)	Alexandrite: Hair reduction, pigmented lesion treatment, wrinkles, vascular lesions. Nd:YAG: Incision, vaporization, coagulation, hemostasis, hair reduction, wrinkles, acne vulgaris, pigmented/vascular lesions, podiatry, onychomycosis, pain relief.

2. Sample size used for the test set and the data provenance
Not applicable. This device is a laser surgical instrument, and the provided document does not describe a performance study with a test set of data samples (e.g., medical images, patient records). The evaluation is based on non-clinical testing of the device itself (electrical, mechanical safety, software V&V, biocompatibility) and a comparison of its technical specifications and intended use against legally marketed predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as there is no "test set" or "ground truth" establishment in the context of an AI/ML performance study described. The document relies on recognized standards and the established safety and efficacy of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication.

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
No. This device is a laser surgical instrument and does not involve AI assistance for human readers or interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical and functional design, which is assessed through non-clinical bench testing and comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an AI/ML performance study. The "ground truth" for this submission is adherence to established industry safety and performance standards (e.g., IEC, ISO) and demonstrating that the device's technical characteristics and indications for use are substantially equivalent to those of legally marketed predicate devices.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set or its associated ground truth.

Summary

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January 19, 2023

Fotona d.o.o. Tina Bartolic Ouality Assurance and Regulatory Affaris Stegne 7 Ljubljana, 1000 Slovenia

Re: K223540

Trade/Device Name: AvalancheLase Family 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: November 24, 2022 Received: November 25, 2022

Dear Tina Bartolic:

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

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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 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 medical devices and radiation-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,

Image /page/1/Picture/5 description: The image shows the text "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain and does not distract from the text.

Jianting Wang Acting Assistant Director 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

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Indications for Use

510(k) Number (if known) K223540

Device Name AvalancheLase Family

Indications for Use (Describe)

The AvalancheLase Family and its accessories will be marketed for the following indications for use:

Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics

· Temporary hair reduction.
· Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment 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 I- VI) including tanned skin.
· Treatment of benign pigmented lesions.
Treatment of wrinkles

· The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd:YAG laser (1064 nm wavelength):

The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

Indications in Dermatology and Aesthetics:

· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned thair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6.9 and 12 months after the completion of a treament regime.

· Treatment of wrinkles.

· Treatment of wrinkles with S11 (LX Runner) scanner.
· Treatment of mild to moderate inflammatory acne vulgaris.

· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains,

hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
· Podiatry (ablation, vaporization, incision, and coagulation of soft tissue) including:
Matrixectomy
Radical nail excision
Periungual and subungual warts
Plantar warts
Neuromas

· Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

NNd:YAG laser (1064 nm wavelength) therapy:

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• Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood
circulation and/or promoting relaxation of muscle.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary

SUBMITTER'S INFORMATION

Submitter:

Fotona d.o.o. Stegne 7 1000 Ljubljana, Slovenia Phone: +386 1 5009 100 Fax: + 386 1 5009 200

Contact Person:

Tina Bartolic, Quality Assurance and Regulatory Affairs Phone: + 386 1 5009 100 E-mail: tina.bartolic@fotona.com

Date:

January 6, 2023

DEVICE INFORMATION

Device Trade Name:	AvalancheLase Family
Common name:	Medical Laser System
Classification name:	Laser Surgical Instrument For Use In General And Plastic SurgeryAnd In Dermatology (21 CFR 878.4810; Class II)
Product Code:	GEX

PREDICATE DEVICES

Dynamis Pro Family (K213267) Family of CoolGlide Aesthetic Lasers (K153671) GentleMAX Family of Laser Systems (K201111) GentleLASE Family of Laser Systems (K140732) DEKA MOTUS AX (K162886)

DEVICE DESCRIPTION SUMMARY

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The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).

INTENDED USE/INDICATIONS FOR USE

The AvalancheLase Family and its accessories will be marketed for the following indications for use:

Alexandrite laser (755 nm wavelength):

Indications in Dermatology and Aesthetics

· Temporary hair reduction.
· Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. Permanent hair reduction is defined as the longterm, 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 I- VI) including tanned skin.
- · Treatment of benign pigmented lesions.
- Treatment of wrinkles.
- · The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Nd:YAG laser (1064 nm wavelength):

The Nd:YAG laser module is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.

Indications in Dermatology and Aesthetics

· Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
· Treatment of wrinkles.
· Treatment of wrinkles with S11 (LX Runner) scanner.
· Treatment of mild to moderate inflammatory acne vulgaris.
· Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins;
· Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision

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Periungual and subungual warts
Plantar warts
Neuromas
· Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

Nd:YAG laser (1064 nm wavelength) therapy:

· Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.

INDICATIONS FOR USE COMPARISON

The indications for use from the predicate devices that are included in the AvalancheLase Family do not raise new types of questions regarding safety and effectiveness. The indications with the Nd:YAG (1064 nm) and Alexandrite (755 nm) laser output are based on previously cleared indications of predicate devices.

TECHNOLOGICAL COMPARISON

A comparison of the technical specifications for the intended use of the AvalancheLase Family with the previously cleared device is provided in Table 1.

Table 1: The comparison of technical capabilities and characteristics between Dynamis Pro Family (K213267), Family of CoolGlide Aesthetic Lasers (K153671), GentleMAX Family of Laser Systems (K201111), GentleLASE Family of Laser Systems (K140732) and DEKA MOTUS AX (K162886) and AvalancheLase Family (this submission) for the Alexandrite and Nd:YAG laser wavelengths

	FotonaDynamisProFamily(K213267)	CuteraFamily ofCoolGlideAestheticLasers(K153671)	CandelaGentleMAXFamily ofLaserSystems(K201111)	CandelaGentleLASEFamily ofLaserSystems(K140732)	DEKAMOTUSAX(K162886)	Fotona AvalancheLaseFamily(this submission)
	Nd:YAG	Alexandrite	Alexandrite	Alexandrite	Alexandrite	Alexandrite	Nd:YAG
Wavelength	1064 nm	755 nm	755 nm	755 nm	755 nm	755 nm	1064 nm
Lasermedia	Flashlampsolid stateNd:YAG rod	Flashlampsolid stateAlexandriterod	Flashlamp solidstateAlexandrite rod	Flashlamp solidstate Alexandriterod	Flashlampsolid stateAlexandriterod	Flashlampsolid stateAlexandriterod	Flashlampsolid stateNd:YAG rod
Aimingbeam	650 nm	635 nm	520-550 nm	520-550 nm	532 nm	520 nm	520 nm
Outputmode	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed	Pulsed
Fluence	Up to 600J/cm²	Up to 100J/cm²	Up to 400 J/cm²	53 J/cm²	Up to 600J/cm²	Up to 500J/cm²	Up to 600J/cm²
Spotsize	2-20 mm	5 - 18 mm	1.5 -26 mm	6-24 mm	2.5-20 mm	2-30 mm	2-30 mm

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Pulse width	0.1 - 50 ms	3 ms	0.25-100 ms	3-300 ms	0.25-300 ms	0.2 – 200 ms	0.1 - 200 ms
Repetitionrate	Up to 100 Hz	< 2 Hz andsingle shot	Up to 10 Hz	Max 2 Hz	Up to 10 Hz	Up to 60 Hz*	Up to 80 Hz
BeamDelivery	Fiber	Fiber	Fiber	Fiber	Fiber	Fiber	Fiber
Systemcooling	Self-contained,water to airheatexchanger	Self-contained,water to airheatexchanger	Self-contained,water to airheatexchanger	Self-contained,water to airheat exchanger	Self-contained,water to airheatexchanger	Self-contained,water to airheatexchanger	Self-contained,water to airheatexchanger
UserInterface	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen	LCDTouchscreen

*Not all repetition rate and fluence combinations are possible.

NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS

Non-Clinical Summary:

The AvalancheLase Family has been evaluated via verification and validation tests and inspections for conformance to the applicable regulations and safety standards. The AvalancheLase Family is designed, tested and will be manufactured in accordance with both, mandatory and voluntary standards:

AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

IEC 60601-2-22:2007 + A1:2012

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.

IEC 60601-1-6:2010 + A1:2013

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

IEC 60601-1-9:2007 + A1:2013

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral standard: Requirements for environmentally conscious design.

IEC 60825-1:2014

Safety of laser products. Part 1: Equipment classification and requirements.

IEC 62366:2007 + A1:2014

Medical devices - Application of usability engineering to medical devices.

IEC 62366-2015

Medical devices - Part 1: Application of usability engineering to medical device

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IEC 62304:2006 + A1:2015

Medical device Software - software life-cycle process.

ISO standards:

ISO 14971:2019

Medical devices - Application of risk management to medical devices

ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices

ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices

ISO 10993-1:2018 (state-of-the-art edition)*

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

Software verification/validation

AvalancheLase Family is a laser device controlled by software. Software verification and validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.

Biocompatibility

Biological evaluation according to ISO 10993-1 and the FDA guidance recommendations was performed on handpieces and scanner, which are the only parts that come in direct contact with the patient. Based on nature of body contact and the duration (time) of contact the following endpoints were considered: Physical and/or Chemical Information, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity and Acute Systemic Toxicity.

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Clinical Summary:

No premarket clinical investigations for AvalancheLase Family were conduceted since the performance of the device under evaluation is based on well-established laser technology with long history of use for the same intended purpose and it is addtionally sufficently supported by clinical trials assessing performance and safety published in peer reviewed scientific journals.

Conclusions:

The AvalancheLase Family indications for use and technological characteristics do not raise new types of questions regarding safety and efficacy when compared to the predicates. Based on its technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the AvalancheLase Family is considered to be as safe, as effective and to perform as well as the predicate devices.

Regulation Number and Section

§ 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.