The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in coniunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Device Description

The INTERmedic Diode Laser Family is designed to deliver laser power at wavelengths of 810nm and 980nm, depending on model, that can be used for the procedures indicated in the section "Indication for Use" in this summary. The ContrÂge model can be used with or without the RF unit. The different models can be identified by their different names, output frequency and maximum power. Each system is comprised with the following main components: Operating software controlled by a microprocessor, A footswitch (detachable), A laser cabinet/console with fiber port, A safety Interlock.

AI/ML Overview

The provided document is a 510(k) summary for the INTERmedic Diode Laser Family. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria in a clinical setting.

Therefore, many of the requested elements for describing an acceptance criteria study (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) are not applicable and not present in this type of regulatory submission.

The document primarily focuses on demonstrating substantial equivalence based on technological characteristics and intended use compared to predicate devices.

However, I can extract information related to the device's technical specifications and intended uses, which serve as the basis for the FDA's determination of substantial equivalence.

Here's the partial information that can be extracted, framed within the context of the device's substantial equivalence claim:

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

In the context of a 510(k) submission, "acceptance criteria" for the new device largely revolve around demonstrating that its performance specifications and indications for use are substantially equivalent to those of the predicate devices. The "reported device performance" is a comparison of these technical specifications and intended uses.

The tables in the document compare the INTERmedic Diode Laser Family models with various predicate devices. Below is a synthesized table based on these comparisons, highlighting key characteristics that are compared for substantial equivalence.

Feature / Model	INTERmedic ENDO Laser (980nm)	INTERmedic SURGICAL Laser (980nm)	INTERmedic PL3D (980nm)	INTERmedic ContrÂge (980nm + RF)	INTERmedic SLP (810nm)	INTERmedic VARIUS / VARIUS 1000 (980nm)	INTERmedic ODONT (800-980nm)
Acceptance Criteria (Predicate Device Specification)	Dornier K020339 Medilas: Wavelength 940nm, Peak Power 120W, Pulse Mode 10-100ms, Same Indications for use.	BioLitec K050824 Medilas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use.	BioLitec K050824 Ceralas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use.	Syneron K052324/K050452/K0507796 Polaris/Aurora: Wavelength 900-980nm, Peak Power Up to 100W, Same Indications for use.	Dornier K050824/K021724/K020339 Medilas D Skin Pulse: Wavelength 940nm, Peak Power 120W, Same Indications for use.	Dornier K050824/K021724/K020339 Medilas D Skin Pulse: Wavelength 940nm, Peak Power 120W, Same Indications for use.	BioLitec K050824 Ceralas: Wavelength 980nm, Peak Power 100W, Exp. Time 0.01-99.9s, Same Indications for use.
Reported Device Performance (INTERmedic Device)	INTERmedic ENDO Laser: Wavelength 980nm, Peak Power 50W, Pulse Mode 5ms to 10s, Same Indications for use (Minimally invasive endovenous treatment).	INTERmedic SURGICAL Laser: Wavelength 980nm, Peak Power Up to 120W, Exp. Time 5ms to 10s, Same Indications for use (broad surgical applications).	INTERmedic PL3D: Wavelength 980nm, Peak Power Up to 25W, Exp. Time 50ms to cw, Same Indications for use (Neurosurgery).	INTERmedic ContrÂge: Wavelength 980nm, Peak Power Up to 40W, RF Freq 0.45MHz, RF Energy 50-150 J/cm², Same Indications for use (Aesthetics, Dermatology, wrinkle reduction).	INTERmedic SLP: Wavelength 810nm, Peak Power Up to 90W, Exp. Time 5-500ms (vascular), 50-1200ms (hair removal), Same Indications for use (Dermatology, vascular/hair removal).	INTERmedic VARIUS/VARIUS 1000: Wavelength 980nm, Peak Power Up to 50W, Pulse interval 50-900ms, Same Indications for use (Dermatology, vascular, skin treatments, cutaneous surgery).	INTERmedic ODONT: Wavelength 800-980nm, Peak Power Up to 50W, Pulse interval 50-900ms, Same Indications for use (Oral Surgery).
Comparison Rationale	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." Wavelength and power are within acceptable range or variations explained (e.g., higher power doesn't affect safety).	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics." (Increase of power to 120W does not affect safety and security characteristics and provides shorter treatment time).	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics."	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics."	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics."	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics."	"Same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics."

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. This document is a 510(k) summary, which does not typically include data from clinical test sets in the manner of a clinical trial. The "test" for substantial equivalence relies on comparing the device's design, specifications, and intended uses 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 (e.g. radiologist with 10 years of experience)

Not Applicable. There is no "test set" or ground truth established by experts in this type of regulatory submission. The FDA reviews the provided technical and descriptive information for substantial equivalence.

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

Not Applicable. No test set or adjudication process as described in clinical studies is reported.

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. This device is a laser surgical instrument, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant.

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

Not Applicable. This device is a physical medical instrument, not an algorithm.

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

Not Applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices as legally marketed, and the demonstration that the new device shares similar technological characteristics and intended uses.

8. The sample size for the training set

Not Applicable. This document does not describe a machine learning model or a training set.

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

Not Applicable. This document does not describe a machine learning model or a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" described in the 510(k) summary is a comparative analysis demonstrating substantial equivalence to predicate devices already cleared by the FDA.

Rationale for Substantial Equivalence: The INTERmedic Diode Laser Family, including its accessories, is claimed to have:
- The same intended uses and indications for use as the listed predicate devices.
- Similar technological characteristics to the predicate devices, specifically mentioning "treatment wavelengths, laser media, mode of operation, power output, exposure duration, treatment intervals, laser energy delivery control."
Methodology: The submission provides detailed specification tables comparing each INTERmedic model (ENDO, SURGICAL, PL3D, ContrÂge, SLP, VARIUS/VARIUS 1000, ODONT) against specific predicate devices (e.g., PhotoMedex Laser Pro, Syneron Lasers, Ceralas D, Dornier's Diode Laser Family). The comparison highlights parameters such as:
- Wavelength (nm)
- Peak Power (W)
- Pulse Mode/Exposure time
- Laser Medium
- Aiming Beam characteristics
- Power Requirements
- Operation Mode (Continuous or Pulsed)
- Physical Dimensions and Weight
- Indications for use (emphasized as being the same or functionally equivalent).
Conclusion of the Comparison: INTERmedic Arfran S.A. believes that "no significant differences exist between the INTERmedic Diode Laser Family and the predicate devices" based on overall performance and technological characteristics, and that "They all work in the same range of wavelength and have the same indications for use." The document explicitly states that the device's introduction provides "no new clinical indications, which have previously demonstrated clinical effectiveness."

This type of submission relies on the established safety and efficacy of the predicate devices. The "proof" is the detailed comparison showing that the new device does not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the bird.

JUN 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intermedic Arfran, S.A. % Arizona Glass Tech, Incorporated Mr. Klaus Sivec 9233 E. Neville Avenue Unit 1128 Meza, Arizona 85212

K053540 Re:

Trade/Device Name: INTERmedic Diode Laser Family 810 nm and 980 nm and the delivery accessories that are used with them to deliver, ultrasound and RF energy, including: MULTIDIODE ENDO™ Laser 15, 25, and 50; Surgical 15", 30", 50", 100", 120" and SR 15
OFT™, MULTIDIODE PL3D™, ContrAge™, RF ContrAge™ MULTIDIODE SLP ™, MULTIDIODE VARIUS™, VR1000™, MULTIDIODE ODONT™

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: September 6, 2006 Received: August 25, 2006

Dear Mr. Sivec:

This letter corrects our substantially equivalent letter of September 6, 2006.

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 (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.

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.

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Page 2- Mr. Klaus Sivec

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Mark N. Melkerson, PhD

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Statement of Indication for Use

510(k) Number: K503540

Device Name: INTERmedic Diode Laser Family 810nm and 980nm and the delivery accessories that are used with them to deliver, ultrasound and RF energy, including: MULTIDIODE ENDO™ laser 15, 25 and 50; Surgical SERIES 15™ , 25™ , 50™, 100™ 120™, OFT™; MULTIDIODE PL3D™; ContrÂge™, RF ContrÂge™; MULTIDIODE SLP™; VARIUS™; VR1000™, ODONT™

Indication for Use:

> LASER 810nm and 980nm

Urology:

. Lesions of external genitalia
Circumcision ●
Condvloma ●
Bladder tumors ●
Bladder neck incisions ●
Vaporization of the prostate ●

General Surgery

. Rectal an anal hemorrhoidectomy
Mastectomy ●
Dermabrasion .
Appendectomy (open and ● laparscopic
. Bowel resection (open and laparscopic)
Colectomy .
Liver resection ●
Resections of organs ●
. Thyriodectomy
Adhesiolysis .
Hepatobiliary tumors .
Thoracotomy ●
Cholecystectomy (open and . Laparscopic)
Condvloma ●
Breast biopsy .

--- Page 1 of 3 (Total pages Indications for use; 3 pages)

Prescription Use × (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BLEOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K053540

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Statement of Indication for Use

510(k) Number: K503540

Neurosurgery:

Percutaneous Disc Decompression ●
Discectomy ●
Hemostasis in conjunction with . meningiomas

Gynecology:

Cervical conization .
Myomectomy .
. Endometrial ablation
Ovarian cystectomy ●
Appendectomy ●

Ophthalmology:

Dacryocystorhinostomy ● transcanalicular
. Open DCR
Tumor excision
Blepharoplasty .

Orthopedics:

Dissect and coagulate ●

Gastroenterology:

. Hemostasis of colonoscopy
Hemostasis of esophageal varices ●
Excision of polyps ●

Arthroscopy:

Chondromalacia ●
Synovectomy ●
. Menisectomy

Thoracic Surgery:

Thoracotomy .
Pulmonary resection ●
. Hemostasis
Pericardiectomy .
Adhesiolysis .
Coagulation of blebs and bullae .

Pulmonology:

Endoscopic pulmonary applications
Tracheal bronchial lesions ●
Benign an malignant pulmonary ● obstruction

Otolaryngology ENT:

Removal of benign lesions from the . ear, nose and throat
Excision of carcinoma of the larynx
Incision and excision of carcinoma ● in situ
Neck dissection ●
Laryngeal papillomectomy
Removal of vocal cord/fold . nodules, polyps and cysts

Dental applications:

Frenectomy ●
Frenotomy
Biopsy .
Pulpotomy as an adjunct to root ● canal therapy and light activation of bleaching materials for teeth whitening

--- Page 2 of 3 (Total pages Indications for use; 3 pages)

Prescription Use × (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BLEOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Office of Device Evaluation (ODE)

Mark A. Wilkerson

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K053540

Over the Counter Use

{4}------------------------------------------------

Statement of Indication for Use

510(k) Number: K503540

Pulmonary Surgery:

Endoscopic pulmonary applications ●
Tracheal bronchial lesions .
Benian and malignant pulmonary or . stricture

Cardiac Surgery:

Coagulation and hemostasis of ● cardiac tissue

Dermatology/Aesthetics:

Photocoagulation of vascular & ● dermatological lesions of the face and extremities
. Photocoagulation of telangiectasia, veinulectasias of the legs and face
Treatment of reticular veins and branch varicosities
Pvogenic granuloma, ● lymphangioma and lymphagiomatosis disease, angiofibromas.
Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.
Dermatological surgery: ● Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment.
Seborrheic keratosis ●
Mixoid cyst ●
Papillary varix ●
Acne treatment ●
Hair removal of unwanted hair from ● skin type I-V

Plastic Surgery:

Cut, coagulation & vaporization ●
Resurfacing non ●
. Blepharoplasty

Vascular Surgery:

Endoluminal or endovenous laser . surgery for saphenous incompetent veins

ContrÂge RF A Dermatology/Aesthetics:

· Non invasive treatment of wrinkles and rhytids
. Non invasive scar reduction treatment (acne or traumatic scars)

--- Page 3 of 3 (Total pages Indications for use; 3 pages)

Prescription Use × (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BLEOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Millerson

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

510(k) Number K053540

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510(k) Summary as required by section 807.92(c) For INTERmedic's Diode Laser Family

K05>540

This summary complies with the Federal Performance Standard for Laser Products issued by the Food and Drug Administration (FDA), Center of Devices and Radiological Health (CDRH), in Title 21, Code of Federal Regulations, Subchapter J, Parts 1040.10 and 1040.11.

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Arizona Glass Tech, Inc. 9233 E. Neville Ave. #1128 Mesa, AZ 85212 Phone: 480-241-3795 480-445-9903 Fax:

as United States Agent/Distributor and official correspondent to INTERmedic Arfran, S.A.

See Attachment 1 (United States Agent Notification)

Contact Person:	Klaus
-----------------	-------

November 25th, 2005 Date of Preparation:

Name/Address of Establishment/Owner:

INTERmedic Arfran, S.A. Avda. Josep Tarradellas, 91 08029 Barcelona SPAIN

Trade Name: INTERmedic Diode Laser Family 810nm and Name of Device: 980nm (and the delivery accessories that are used with them to deliver Laser Energy), including:

MULTIDIODE ENDO™ laser 15, 25 and 50 .
MULTIDIODE SURGICAL 15™, 30™, 50™, 50™, 100™, 120™ . & R 15 OFT™
MULTIDIODE PL3D™ .
ContrÂge™, RF ContrÂge TM .
MULTIDIODE SLP™ .
MULTIDIODE VARIUS™ , VR1000™ ●
MULTIDIODE ODONT™ .

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Common Name	Medical Laser System (and Accessories)
Classification Name	Laser surgical instrument and accessories for use in general andplastic surgery and in dermatology (21 CFR 878.4810)Product code: GEX Laser instrument, surgical, poweredSubsequent product code: GEI Electrosurgical, cutting &coagulation & accessoriesPanel: 79Class: II
Predicate Device	PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems(K042211, K040294)Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324,K041969, K041959, K050796)Ceralas D 980 Diode Laser System (K050824)Ceralas D 810 Diode Laser System (K032864)

Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339)

Rationale for Substantial Equivalence

The INTERmedic Diode Laser Family including Accessories have the same intended uses and indications for uses as the listed predicate devices, and have similar technological characteristics as the predicate devices - treatment wavelengths, laser media, mode of operation, power output, exposure duration, treatment intervals, laser energy delivery control and therefore is substantially equivalent to the predicate devices.

Device Description

Each system is comprised with the following main components:

Operating software controlled by a microprocessor ।
A footswitch (detachable) ।
A laser cabinet/console with fiber port -
A safety Interlock

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Technological Characteristics and Substantial Equivalence

From a clinical point of view and comparing design and specifications, the INTERmedic Diode Laser Family and predicate devices, Ceralas Laser Family from BioLitec, Laser Family from Dornier, Syneron Laser Systems and other listed in predicate devices are substantially equivalent. Based on the overall performance and technological characteristics of the devices. INTERmedic Arfran S.A. believes that no significant differences exist between the INTERmedic Diode Laser Family and the predicate devices. They all work in the same range of wavelength and have the same indications for use.

Indications for use

The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis. or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures. Examples include: (see page 5 in this Summary)

Safety and effectiveness

The INTERmedic Diode Laser Family is designed, manufactured and tested according mandatory and voluntary international Standards. Compared to the previously indicated predicate devices, the introduction of the INTERmedic Diode Laser Family provides no new clinical indications, which have previously demonstrated clinical effectiveness.

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Performance Data - Comparison Tables

	INTERmedicENDO Laser	DornierK020339Medilas
Wavelength [nm]	980	940
Peak Power	50W	120W
Pulse Mode	5ms to 10s	10 to 100ms
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	650nm (red) 5mW max.	Red Standard 0-150µW(adjustable)
Power Requirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	100 - 240 VAC 50-60Hz
Operation Mode	Continuous or pulsed	Continuous or pulsed
Dimensions (HxWxD) [inch]	8x15x19	8x19x20
Weight [lbs]	25	55
Indication for use:	Minimally invasiveendovenous treatmentof varicose veins (internaland external saphenousand collateral veins) of alldiameters under localanesthesia, as wellas percutaneous treatmentsof superficialvascular lesions	Same

	INTERmedicSURGICAL Laser incl. SR OFT 15	BioLitecK050824Medilas
Wavelength[nm]	980	980
Peak Power	Up to 120W	100W
Exposure time	5ms to 10s	0.01s to 99.9s
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	650nm (red) 5mW max.	635nm (red) max.4mW
PowerRequirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	100 - 240 VAC50-60Hz
OperationMode	Continuous or pulsed	Continuous orpulsed
Dimensions(HxWxD) [inch]	8x19x19	7x18x15
Weight [lbs]	35	33
Indication foruse:	vaporization, incision, excision, ablation, cutting and hemostasis, orcoagulation of soft tissue in conjunction with endoscopic equipment formedical specialties including: Urology, Genitourinary (Urology), ThoracicSurgery, Plastic Surgery and Dermatology, including vascular lesionsand hair removal, General Surgery, Ophthalmology, Orthopedics,Podiatry, Arthroscopy, Gynecology, Pulmonary Surgery, Neurosurgery,Gastroenterology, Head/Neck/ENT and Radiology, Endovascularcoagulation, Oral Surgery and Dental procedures.	same

The increase of power to 120W does not affect any safety and security characteristics. The 120W contains additional diodes and has a shorter treatment time on the patient, compare to a 100W or a laser using less wattage..

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	INTERmedic	BioLitec
	PL3D	K050824
		Ceralas
Wavelength [nm]	980	980
Peak Power	Up to 25W	100W
Exposure time	50ms to cw	0.01-99.9s
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	650nm (red) 5mW max.	635nm (red) max.4mW
Power Requirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	100 - 240 VAC50-60Hz
Operation Mode	Continuous or pulsed	Continuous orpulsed
Dimensions(HxWxD) [inch]	8x19x19	7x18x15
Weight [lbs]	35	33
Indication for use:	Neurosurgery: vaporization, incision, excision, ablation, andcoagulation of peripheral soft tissue tumors, discectomy.	Same

	INTERmedicContrÂge and RF ContrÂge	SyneronK052324,K050452,K0507796Polaris, Aurora
Wavelength [nm]	980	900-980
Peak Power	Up to 40W	Up to 100W
Exposure time	5ms to cw	n.a.
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	650nm (red) 5mW max.	n.a.
Power Requirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	Standard 110VAC
Operation Mode	Continuous or pulsed	Continuous orpulsed
Dimensions (HxWxD) [inch]	8x20x16	35.5x15x15
Weight [Ibs]	40 + 22 with RF unit	55
RF Frequency	0.45 MHz	n.a.
RF Energy	50 - 150 J/cm²	Up to 100 J/cm²
Indication for use:	Aesthtetic, Dermatology for vascular lesions, superficialBenign vascular and pigment lesion treatment,Skin rejuvenation, wrinkle reduction	Same

The ContrÂge laser and RF unit is not an anti aging laser.

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	INTERmedicSLP	DornierK050824, K021724, K020339Medilas D Skin Pulse
Wavelength [nm]	810	940
Peak Power	Up to 90W	120W
Exposure time	5 to 500ms (vascular mode)50 to 1200ms (hair removalmode)	10 to 100ms
Repetition Rate	1 to 9Hz	Up to 5Hz
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	650nm (red) 5mW max.	Red aiming beam standard 0-150mW adjustable
Power Requirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	100-240 VAC 50-60Hz
Operation Mode	Continuous or pulsed	Continuous or pulsed
Dimensions (HxWxD) [inch]	8x20x18	8x19x20
Weight [Ibs]	27	55
Indication for use:	Dermatology, treatment and/orremoval of unwanted vascularlesions and removal ofunwanted hair, pigmentlesions	Same

	INTERmedicVARIUS and VAIRUS 1000	DornierK050824, K021724, K020339Medilas D Skin Pulse
Wavelength [nm]	980	940
Peak Power	Up to 50W	120W
Pulse interval	50 to 900ms	10 to 100ms
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	635nm (red), 1mW	Red Standard 0-150µW(adjustable)
Power Requirements	100-120 VAC 50-60Hz220-240 VAC 50-60Hz	100 - 240 VAC 50-60Hz
Operation Mode	Continuous or pulsed	Continuous or pulsed
Dimensions (HxWxD) [inch]	8x15x19	8x19x20
Weight [lbs]	26	55
Indication for use:	Dermatology, Vasculartreatment of leg and spider veins,vascular and pigmented lesionsand skin treatments and rejuventationcutaneous surgery: cutting, coagulationand vaporization	Same

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	INTERmedicODONT	BioLitecK050824Ceralas
Wavelength [nm]	800-980	980
Peak Power	Up to 50W	100W
Pulse interval	50 to 900ms	0.01-99.9s
Laser Medium	Solid-state Diode	Solid-state Diode
Aiming Beam	635nm (red), 1mW	635nm (red) max. 4mW
Power Requirements	100-240 VAC 50-60Hz	100 – 240 VAC 50-60Hz
Operation Mode	Continuous or pulsed	Continuous or pulsed
Dimensions (HxWxD) [inch]	7x12x16	7x18x15
Weight [Ibs]	18	33
Indication for use:	Oral Surgery, examples include:Root sterilization, hemostasis, biopsy,frenectomy, fibroma removal,abscess incision and draining, pulpotomy,	Same

and the comments of the comments of the comments of the comments of

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.