Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system for surgical procedures and does not mention any AI or ML components.

Therapeutic

Yes
The device is described as a laser system intended for use in surgical procedures to perform various soft tissue interventions across multiple medical specialties, indicating its use in treating medical conditions.

Diagnostic

No.

The device description indicates its use in surgical procedures for incision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, which are all therapeutic functions. There is no mention of diagnostic capabilities, such as identifying or evaluating a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Laser system" and includes physical components like a "control panel" and "Foot switch," indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical laser system used for procedures directly on soft tissue within the body (incision, resection, ablation, etc.). This is an in-vivo application.
Device Description: The description details a laser system and fiber optic delivery system designed to transmit laser energy to tissue. This is consistent with a surgical device, not a device that analyzes samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening.

This device is a surgical laser system used for therapeutic and procedural purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and use in medical specialties including: Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery,

Urology
Open and endoscopic surgery (incision, resection, ablation, vaporization, coazulation and hemostas) including:

· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Turnors
· Ablation of Benign Prostatic Hypertrophy (BHP),
· Transurethral incision of the prostate (TUIP)
· Holmiurn Laser Resection of the Prostate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmiurm laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy
· Endoscopic fragmentation of vrethral, ureteral, bladder and renal calculi including cystine, calcium oxalate,

monohydrate and calcium oxalate
· dehydrate stones.
· Endoscopic fragmentation of kidney calculi
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
· Polyps
· Biopsy
· Gall Bladder calculi
· Biliary/Bile duct calculi
· Ulcers
· Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
· Pancreatitis
· Hemorrhoids
· Cholecystectomy
· Benign and Malignant Neoplasm · Angiodysplasia
· Colorectal cancer
on re ano legiosias
· Telangiectasias of the Osler-Weber-Renu disease
· Vascular Malformation
· Gastritis
· Esophagitis
· Esophageal ulcers
· Varices
Colitis
· Mallory-Weiss tear
· Gastric Erosions

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

· Ligament and tendon Release
· Contouring and sculpting of articular surfaces
· Capsulectomy in the knee
· Chondreoplasty in the knee
· Debridement of inflamed synovial tissue
· Chondromalacia Ablation
· Chondromalacia and tears
· Plica Removal
· Meniscectomy
· Loose body Debridement
· Lateral retineacular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

· Percutaneous Laser Disc Decompression/Discectorny of the L4-5 and L5-S1 Iumbar discs, including Forminoplasty
· Percutaneous Cervical Disc Decompression/Discectomy
· Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue)

Gynecology
Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

ENT
Endoscopic endomasal surgery (incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including:

· Endonasal / sinus Surgery
· Partial turbinectomy
· Polypectomy
· Dacryocystorhinostomy
· Frontal Sinustomy
· Ethmoidectomy
· Maxillary antrostomy
· Functional endoscopic sinus surgery

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

· Basal Cell Carcinomas
· Lesions of skin and subcutaneous tissue
· Skin tags
· Plantar warts
· Lesions of skin and subcutaneous tissue
· Port Wine Stains
· Papillomas

General Surgery
Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

· Appendectomy
· Skin incision
· Excision of external lesions
· Complete or partial resection of internal organs, tumors and lesions
· Biopsy

Product codes

GEX

Device Description

The MultiPulse HoPLUS Laser system and its fiber optic delivery system is a laser Class IV, pulsed, solid state Holmium-YAG, which emits laser radiation with a wavelength of approximately 2100 nm with a pulse with between 150-850 microseconds. The laser power up to 110 Watts is transmitted to the tissue through different optical fibers. The laser system consists of: Laser system including control panel (user interface) Foot switch

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urethral, bladder, ureteral, prostate, external genitalia, kidney, gastrointestinal tract, small and large joints (excluding spine), L4-5 and L5-S1 lumbar discs, cervical discs, thoracic discs, pulmonary tissue, gynecological tissue, endonasal, sinus, skin, subcutaneous tissue, mucosal tissue, fatty tissue, cartilaginous tissue, internal organs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The MultiPulse HoPLUS laser system is tested according to following standards:
ISO 14971:2009
DIN EN 60601-1:2006
DIN EN 60601-1-2:2007
DIN EN 60601-1-6:2007
DIN EN 60601-2-22:1996
DIN EN 60825-1:2007
DIN EN 62304:2006

The device also complies with European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111475, K002308, K011703

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion. The seal is black and white.

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

October 15, 2014

ASCLEPION LASER TECHNOLOGIES GmbH Mrs. Antje Katzer International Regulatory Affairs Manager Brüesseler Straße 10 Jena 07747, Germany

Re: K131987

Trade/Device Name: MultiPulse HoPLUS 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: August 8. 2014 Received: October 9, 2014

Dear Mrs. Katzer:

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

1

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of 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 yours,

Binita S. Ashar -S 2014.10.15 07:49:43 -04'00'

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

2

Indications for Use

510(k) Number (if known) K131987

Device Name

Multipulse HoPLUS

Indications for Use (Describe)

The MultiPulse HoPLUS Laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and use in medical specialties including: Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery,

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coazulation and hemostas) including:

· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Turnors
· Ablation of Benign Prostatic Hypertrophy (BHP),
· Transurethral incision of the prostate (TUIP)
· Holmiurn Laser Resection of the Prostate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmiurm laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

· Endoscopic fragmentation of vrethral, ureteral, bladder and renal calculi including cystine, calcium oxalate,

monohydrate and calcium oxalate
· dehydrate stones.
· Endoscopic fragmentation of kidney calculi
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
· Polyps
· Biopsy
· Gall Bladder calculi
· Biliary/Bile duct calculi
· Ulcers
· Gastric ulcers
· Duodenal ulcers
· Non Bleeding Ulcers
· Pancreatitis
· Hemorrhoids
· Cholecystectomy
· Benign and Malignant Neoplasm · Angiodysplasia
· Colorectal cancer

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

3

on re ano legiosias

· Telangiectasias of the Osler-Weber-Renu disease
· Vascular Malformation
· Gastritis
· Esophagitis
· Esophageal ulcers
· Varices
Colitis
· Mallory-Weiss tear
· Gastric Erosions

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

· Ligament and tendon Release
· Contouring and sculpting of articular surfaces
· Capsulectomy in the knee
· Chondreoplasty in the knee
· Debridement of inflamed synovial tissue
· Chondromalacia Ablation
· Chondromalacia and tears
· Plica Removal
· Meniscectomy
· Loose body Debridement
· Lateral retineacular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

· Percutaneous Laser Disc Decompression/Discectorny of the L4-5 and L5-S1 Iumbar discs, including Forminoplasty
· Percutaneous Cervical Disc Decompression/Discectomy
· Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonary

Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

ENT

Endoscopic endomasal surgery (incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including:

· Endonasal / sinus Surgery
· Partial turbinectomy
· Polypectomy
· Dacryocystorhinostomy
· Frontal Sinustomy
· Ethmoidectomy
· Maxillary antrostomy
· Functional endoscopic sinus surgery

4

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, vaporization and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

· Basal Cell Carcinomas
· Lesions of skin and subcutaneous tissue
· Skin tags
· Plantar warts
· Lesions of skin and subcutaneous tissue
· Port Wine Stains
· Papillomas

General Surgery

Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

· Appendectomy
· Skin incision
· Excision of external lesions
· Complete or partial resection of internal organs, tumors and lesions
· Biopsy

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONTRACTOR CONSTITUTION OF FOR FOR FOR FOR FOR FOR THE CONSTITUTION OF CONSULTION

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 valld OMB number."

5

510(k) SUMMARY ASCLEPION LASER TECHNOLOGIES GmbH MultiPulse HoPlus

This 510(k) summary of safety and effectiveness for the Asclepion Laser Technologies GmbH MultiPulse HoPLUS is submitted in accordance with the requirements of 21 CFR 907.92 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

| Applicant: | ASCLEPION LASER TECHNOLOGIES GmbH
Bruesseler Str. 10
07747 Jena, Germany | | |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|------------------------------------|
| Contact Person: | Mrs. Antje Katzer
Product Management and
International Regulatory Affairs | | |
| Phone:
Fax:
e-mail: | +49 3641 77 00 309
+49 3641 77 00 302
antje.katzer@asclepion.com | | |
| Preparation Date: | August 28, 2014 | | |
| Device Name: | MultiPulse HoPLUS | | |
| Common Name: | MultiPulse HoPLUS | | |
| Classification Name: | Laser surgical instrument for use in general and plastic
surgery
79-GEX
21 CFR 878.4810 | | |
| Equivalent Devices: | Auriga XL
Trimedyne Systems
PowerSuite Holmium | K111475
K002308
K011703 | StarMedTec
Trimedyne
Lumenis |
| Device Description: | The MultiPulse HoPLUS Laser system and its fiber optic
delivery system is a laser Class IV, pulsed, solid state
Holmium-YAG, which emits laser radiation with a
wavelength of approximately 2100 nm with a pulse with
between 150-850 microseconds. The laser power up to
110 Watts is transmitted to the tissue through different
optical fibers.
The laser system consists of:
Laser system including control panel (user interface)
Foot switch | | |

6

The MultiPulse HoPLUS Laser system and its fiber optic Intended Use: delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation. vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coaqulation and hemostasis) including:

Urethral Strictures .
Bladder Neck Incisions (BNI) ●
Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors .
Ablation of Benign Prostatic Hypertrophy (BHP) ●
Transurethral incision of the prostate (TUIP)
Holmiurn Laser Resection of the Prostate (HoLRP)
Holmium Laser Enucleation of the Prostate (HoLEP)
Holmiurm laser Ablation of the Prostate (HoLAP)
Condylomas ●
. Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate
dehydrate stones.
Endoscopic fragmentation of kidney calculi ●
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy ●
Polyps ●
Biopsv ●
Gall Bladder calculi ●
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers ●
. Pancreatitis
. Hemorrhoids
Cholecystectomy
Benign and Malignant ● Neoplasma
Angiodysplasia .
Colorectal cancer ●
Telangiectasias ●
Telangiectasias of the Osler-Weber-● Renu disease
. Vascular Malformation
. Gastritis
Esophagitis ●
Esophaqeal ulcers
Varices ●
Colitis .
Mallory-Weiss tear .
. Gastric Erosions

7

Arthroscopy

Arthroscopy / Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

Ligament and tendon Release ●
Countouring and sculpting of articular surfaces ●
Capsulectomy in the knee
Chondreplasty in the knee ●
. Debridement of inflamed synovial tissue
. Chondromalacia Ablation
Chondromalacia and tears
Plica Removal
Meniscectomy ●
Loose Body Debridement ●
Lateral retineacular release ●

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI Iumbar ● discs, including Forminoplasty
Percutaneous Cervical Disc Decompression/Discectomy
Percutaneous Thoracic Disc Decompression/Discectomy

Pulmonarv

Open and endoscopic pulmonary surgery (incision, resection, ablation, Vaporization, coaqulation and haemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including:

. Endonasal / sinus Surgery
Partial turbinectomy ●
Polypectomy
. Dacryocystorhinostomy
. Frontal sinustomy
Ethmoidectomy
Maxillary antrostomy ●
. Functional endoscopic sinus surgery

8

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas ●
Lesions of skin and subcutaneous tissue
Skin tags ●
. Plantar warts
. Lesions of skin and subcutaneous tissue
. Port Wine Stains
Papillomas

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy ●
. Skin incision
Excision of external and internal lesions
. Complete or partial resection of internal organs, tumors and lesions
. Biopsy

Comparison to: The Multipulse HoPLUS surgical laser and delivery devices with Accessories share the same intended use, similar design features, functional features, and therefore, is substantially equivalent to the VersaPulse PowerSuite Holmium (Ho:YAG). The Multipulse HoPlus is also substantially equivalent in terms of indications for use to the Auriga XL (K111475) system Trimedyne Holmium Laser Systems (model 1210, model 1010-VHP and model 1500-A) (K002308) and PowerSuite Holmium (K011703) with similar parameters and the same intended use.

Performance Testing:

The MultiPulse HoPLUS laser system is tested according to following standards:

ISO 14971:2009 DIN EN 60601-1:2006 DIN EN 60601-1-2:2007 DIN EN 60601-1-6:2007 DIN EN 60601-2-22:1996 DIN EN 60825-1:2007 DIN EN 62304:2006

The device also complies with European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC.

9

Conclusion: The Multipulse HoPLUS is substancially equivalent to the cited legally marked predicate devices. Furthermore, the nonclinical data demonstrate the safety and effectiveness of the device for the treatment of the intended indications.