The Hyper Photonics's HYPHO (Ho:YAG) Surgical Laser and Delivery Devices and Accessories (Hyper Photonics optical fibers) is intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; E.N.T. surgery; gynecological surgery; pulmonary surgery; gastroenterology surgery; dermatology and plastic surgery and general surgery. The HYPHO Laser System and its delivery system (Hyper Photonics optical fibers) are indicated for use in the performance of specific surgical applications as follows: Urology - Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH) - Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: = bladder; ■ superficial and invasive bladder, urethral and ureteral tumors; ▪ condylomas: · lesions of external genitalia; · ureteral and penile hemangioma; · ureteral strictures; ■ bladder neck obstructions Urinary Lithotripsy including: o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones; o treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Arthroscopy o Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including: meniscectomy; plica removal; ligament and tendon release; contouring and sculpting of articular surfaces; debridemnent of inflamed synovial tissue (synovectomy); loose body debridement; chondromalacia and tears; lateral retinecular release: capsulectomy in the knee; chondroplasty in the knee; chondrornalacia ablation. o Discectomy including: percutaneous vaporization of the L4-5 and L5-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery o Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy: lysis of adhesions; appendectomy; biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon; skin incision: tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors and lesions; mastectomy; hepatectomy: pancreatectomy; splenectomy; thyroidectomy; parathyroidectomy; hemniorrhaphy: tonsillectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma: debridement of decubitus ulcer; hemorrhoids: debridenment of statis ulcer; biopsy. ENT Surgery o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: partial turbinectomy; ethmoidectorny; polypectomy: maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS). Gynecological Surgery o Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery o Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: gall bladder calculi: biliary /bile duct calculi; benign and malignant neoplasm; polyps: colitis; ulcers: angiodysplasia; hemorrhoids: varices: esophagitis: esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions: colorectal cancer; gastritis: bleeding tumnors; pancreatitis: vascular malformations: telangiectasis; telangiectasias of the Osler-Weber-Renu disease. Pulmonary Surgery o Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in therapeutic plastic, dermatologic and aesthetic surgical procedures. including: scars; tattoo removal: vascular lesions: port wine stains; hemangioma; telangiectasia of the face and leg; rosacea: corns: papillomas: basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts: periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization.

Device Description

The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber. The HYPHO Laser System is designed with six major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: a Ho:YAG laser rod, capable of generating laser pulses at 2100 nm wavelength and a frequency up to 30 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and surgical hand piece. A RFID recognition system is included to read the fiber diameter and the number of reuses directly from the fiber equipped with the suitable transponder; (5) PC embedded with 7" display and Control Electronics which regulates the functions of the laser and allows parameter selection by the user, (6) Optical fibers (Hyper optical fibers) equipped with the transponder for recognition of core diameter and for the management of number of reuses. In addition to the six subsystems, the HYPHO Laser System incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch. Moreover, the system features two laser emission indicators: a Led stripe located on the top of the frontal panel and a buzzer. The led stripe is green in READY mode and blue in EMISSION mode. The buzzer sounds during laser emission. The HYPHO Laser System is operated via proprietary FW and SW. The SW communicates with embedded FW in the main processor and manages Graphical User Interface (GUI) running on the PC embedded.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the "HYPHO Laser System" from Hyper Photonics S.r.l. This type of document focuses on establishing substantial equivalence to a predicate device, rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way a clinical trial or AI algorithm validation study would.

Therefore, the request for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC effectiveness studies is not directly applicable to the information provided in this 510(k) summary. These summaries typically describe the type of testing performed to demonstrate safety and effectiveness for a laser surgical instrument, without going into specific numerical performance data or clinical study designs.

However, I can extract what is provided about the validation.

Here's an attempt to answer your questions based on the provided text, highlighting where the information is not present in a typical 510(k) context:

This document does not pertain to an AI/ML powered device, nor does it present a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study. This is a 510(k) premarket notification for a laser surgical instrument, primarily demonstrating substantial equivalence to predicate devices through technical performance and safety testing.

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

A table of specific quantitative acceptance criteria (e.g., in terms of accuracy, precision, sensitivity, specificity) and corresponding reported performance is not provided in this 510(k) summary. The document states that "Test results indicated that the subject HYPHO Laser system performs in accordance with its requirements and specifications, in similarity with its predicate devices." This is a qualitative statement of successful testing rather than specific numerical performance data.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided in this type of submission. The "test set" in this context refers to the device itself undergoing engineering and bench tests, not a dataset of patient cases.

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)

This information is not applicable/not provided. Ground truth in the context of this device would relate to the clinical outcome of surgical procedures, which is not the focus of this 510(k) submission for substantial equivalence. The "tests" mentioned are primarily engineering and safety tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. Adjudication methods are typically used in clinical studies or AI algorithm validation to resolve discrepancies in expert interpretations, which is not the type of testing described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a laser surgical instrument, not an AI diagnostic or assistance tool, so MRMC studies and "human readers improve with AI" metrics are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm-only performance study was not done. This is a physical surgical laser device, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable/not provided in the context of the described performance activities. The performance activities listed are:

Risk analysis
Electrical and laser safety and electromagnetic compatibility testing
Software verification and validation
System testing (e.g., footswitch, emission indicator, emergency button, ON/OFF button)

For these tests, "ground truth" would be defined by engineering specifications, safety standards, and functional requirements, not clinical outcomes or expert consensus on a dataset.

8. The sample size for the training set

This information is not applicable/not provided. This device does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable/not provided, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2017

Hyper Photonics Srl % Mark Job Regulatory Technology Services. LLC 1394 25th Street. Nw Buffalo, Minnesota 55313

Re: K163449

Trade/Device Name: HyPHo 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: June 9, 2017 Received: June 12, 2017

Dear Mark Job:

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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.

Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The text is black and appears to be against a white background. There is a faint watermark in the background that says "FDA".

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) K163449

Device Name HyPHo Surgical Laser System

Indications for Use (Describe)

chondromalacia and tears;

lateral retinecular release:

capsulectomy in the knee;

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chondrornalacia ablation. o Discectomy including: percutaneous vaporization of the L4-5 and L5-SI lumbar discs of the vertebral spine; open and arthroscopic spine procedures; foraminotomy. General Surgery o Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including: cholecystectomy: lysis of adhesions; appendectomy; biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon; skin incision: tissue dissection; excision of external tumors and lesions; complete or partial resection of internal organs, tumors and lesions; mastectomy; hepatectomy: pancreatectomy; splenectomy; thyroidectomy; parathyroidectomy; hemniorrhaphy: tonsillectomy; lymphadenectomy; partial nephrectomy; pilonidal cystectomy; resection of lipoma: debridement of decubitus ulcer; hemorrhoids: debridenment of statis ulcer; biopsy. ENT Surgery o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including: partial turbinectomy; ethmoidectorny; polypectomy: maxillary antrostomy; frontal sinusotomy; sphenoidotomy; dacryocystorhinostomy (DCR); functional endoscopic sinus surgery (FESS). Gynecological Surgery o Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). Gastroenterology Surgery o Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including: gall bladder calculi: biliary /bile duct calculi; benign and malignant neoplasm; polyps:

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colitis; ulcers: angiodysplasia; hemorrhoids: varices: esophagitis: esophageal ulcer; Mallory-Weiss tear; gastric ulcer; duodenal ulcer; non-bleeding ulcer; gastric erosions: colorectal cancer; gastritis: bleeding tumnors; pancreatitis: vascular malformations: telangiectasis; telangiectasias of the Osler-Weber-Renu disease. Pulmonary Surgery o Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue. Dermatology and plastic surgery Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, intherapeutic plastic, dermatologic and aesthetic surgical procedures. including: scars; tattoo removal: vascular lesions: port wine stains; hemangioma; telangiectasia of the face and leg; rosacea: corns: papillomas: basal cell carcinomas; lesions of skin and subcutaneous tissue; plantar warts: periungual and subungual warts; debridement of decubitus ulcer; skin tag vaporization.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY Hyper Photonics S.r.l. Hyper Photonics HYPHO Laser system

Introduction:

The basis of this submission is New Device The content of this summary is based on the requirements of 21CFR 807.92

Applicant name:

Hyper Photonics S.r.l. Via Lecco 61 20871 Vimercate MB Italy

Contact person:

Isabella Carrer Tel +39 039 89086512 Fax +39 039 89086513

Date prepared:

May 31, 2017

Common name:

Hyper Photonics S.r.1. HYPHO Laser System

Product Code:

GEX

Device Class:

Class II

Regulation Number:

21 CFR 878.4810

Panel:

General & Plastic Surgery

Predicate Devices:

Modified Lumenis VersaPulse PowerSuite Holmiumn (Ho:YAG) Surgical Lasers and - Delivery Devices and Accessories - Lumenis Pulse 120H (K140388); Modified Quanta System LITHO Laser System (K141101). -

Intended use/ Indications for Use:

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Endoscopic transurethral incision of the prostate (TUIP), bladder neck incision of the prostate (BNI), holmium laser ablation of the prostate (HoLAP), holmium laser resection of the prostate (HoLRP), hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy (BPH)
Open and endoscopic urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of:
= bladder;
. ■ superficial and invasive bladder, urethral and ureteral tumors;
트 ▪ condylomas;
I · lesions of external genitalia;
트 · ureteral and penile hemangioma;
I · ureteral strictures;
bladder neck obstructions .

Urinary Lithotripsy including:

o endoscopic fragmentation of urinary (urethral, ureteral, bladder and renal) calculi, including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones;
treatment of distal impacted fragments of steinstrasse when guide wires o cannot be passed.

Arthroscopy

O Arthroscopy (ablation, excision and coagulation of soft and cartilaginous tissue) in various small and large joints of the body, excluding the spine, including:
- . meniscectomy;
- 트 plica removal:
- 트 ligament and tendon release:
- 트 contouring and sculpting of articular surfaces;
- 트 debridemnent of inflamed synovial tissue (synovectomy);
- loose body debridement;
- chondromalacia and tears:
- 트 lateral retinecular release;
- capsulectomy in the knee;

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chondroplasty in the knee;
트 chondrornalacia ablation.
o Discectomy including:
- percutaneous vaporization of the L4-5 and L5-SI lumbar discs of 트 the vertebral spine; open and arthroscopic spine procedures;
- foraminotomy.

General Surgery

O Open, laparoscopic, and endoscopic general surgery (vaporization, ablation, incision, and coagulation of soft tissue) including:
- cholecystectomy;
- 트 lysis of adhesions;
- appendectomy;
- 트 biopsy. pylorostenotomy, and removal of polyps of the sigmoid colon:
- skin incision;
- 트 tissue dissection;
- excision of external tumors and lesions; ■
- complete or partial resection of internal organs, tumors and lesions;
- 트 mastectomy:
- hepatectomy;
- 트 pancreatectomy;
- splenectomy:
- 트 thyroidectomy;
- parathyroidectomy;
- 트 hemniorrhaphy:
- 트 tonsillectomy;
- lymphadenectomy;
- 트 partial nephrectomy;
- 트 pilonidal cystectomy;
- 트 resection of lipoma;
- 트 debridement of decubitus ulcer;
- hemorrhoids;
- debridenment of statis ulcer;
- 트 biopsy.

ENT Surgery

o Endoscopic endonasal/ sinus surgery (ablation, vaporization, incision, and coagulation of soft tissue and cartilage) including:
- partial turbinectomy; I
- ethmoidectorny;
- 트 polypectomy;
- maxillary antrostomy;

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frontal sinusotomy;
트 sphenoidotomy;
dacryocystorhinostomy (DCR); I
트 functional endoscopic sinus surgery (FESS).

Gynecological Surgery

O Open and laparoscopic gynecological surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue).
Gastroenterology Surgery
O Open and endoscopic gastroenterology surgery (ablation, vaporization, incision, excision, resection, coagulation and hemostasis, including:
- gall bladder calculi;
- biliary /bile duct calculi;
- I benign and malignant neoplasm;
- 트 polyps:
- 트 colitis:
- ulcers;
- angiodysplasia;
- 트 hemorrhoids:
- varices;
- 트 esophagitis;
- esophageal ulcer;
- 트 Mallory-Weiss tear;
- gastric ulcer;
- 트 duodenal ulcer;
- 트 non-bleeding ulcer;
- gastric erosions:
- 트 colorectal cancer;
- 트 gastritis:
- 트 bleeding tumnors;
- 트 pancreatitis;
- 트 vascular malformations:
- 트 telangiectasis;
- 트 telangiectasias of the Osler-Weber-Renu disease.

Pulmonary Surgery

O Open and endoscopic pulmonary surgery (cutting, ablation, vaporization, incision, excision and coagulation of soft tissue.
Dermatology and plastic surgery
Incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft, mucosal, fatty and cartilaginous tissues, in

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therapeutic plastic, dermatologic and aesthetic surgical procedures. including:

scars:
트 tattoo removal;
트 vascular lesions:
port wine stains;
트 hemangioma;
I telangiectasia of the face and leg:
rosacea:
트 corns:
트 papillomas:
트 basal cell carcinomas;
트 lesions of skin and subcutaneous tissue;
트 plantar warts:
트 periungual and subungual warts:
트 debridement of decubitus ulcer;
I skin tag vaporization.

Device Description:

The device includes a Ho:Yag laser source with 35W max output power at 2100 nm wavelength. The optical delivery system is an optical fiber.

The HYPHO Laser System is designed with six major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: a Ho:YAG laser rod, capable of generating laser pulses at 2100 nm wavelength and a frequency up to 30 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and surgical hand piece. A RFID recognition system is included to read the fiber diameter and the number of reuses directly from the fiber equipped with the suitable transponder; (5) PC embedded with 7" display and Control Electronics which regulates the functions of the laser and allows parameter selection by the user, (6) Optical fibers (Hyper optical fibers) equipped with the transponder for recognition of core diameter and for the management of number of reuses. In addition to the six subsystems, the HYPHO Laser System incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch. Moreover, the system features two laser emission indicators: a Led stripe located on the top of the frontal panel and a buzzer. The led stripe is green in READY mode and blue in EMISSION mode. The buzzer sounds during laser emission.

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The HYPHO Laser System is operated via proprietary FW and SW. The SW communicates with embedded FW in the main processor and manages Graphical User Interface (GUI) running on the PC embedded.

Substantial Equivalence:

The intended use and indications for use of the HYPHO Laser System are identical to the intended use and indications for use of its predicate devices. In addition the same technological characteristics and principles of operations apply for all systems.

Performance testing was conducted in order to demonstrate the performance of the HYPHO Laser System and to verify that no questions of safety and effectiveness have been raised. The following performance activities were carried out:

o risk analvsis:
o electrical and laser safety and electromagnetic compatibility testing;
o Software verification and validation;
o System testing (e.g. footswitch, emission indicator, emergency button, ON/OFF button).

Test results indicated that the subject HYPHO Laser system performs in accordance with its requirements and specifications, in similarity with its predicate devices. Consequently, it is Hyper Photonics belief that the HYPHO Laser System is as safe as effective for its intended use as its predicates and is substantially equivalent to its predicate devices without raising any safety and/or effectiveness issues.

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.