(260 days)
Not Found
No
The summary describes a diode laser system controlled by a microprocessor, but there is no mention of AI, ML, or related concepts in the device description, intended use, or other sections.
Yes
The device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, which are all therapeutic procedures.
No
The device is indicated for surgical applications such as vaporization, incision, excision, ablation, cutting, coagulation, and hemostasis of soft tissue, which are therapeutic and not diagnostic functions.
No
The device description explicitly lists hardware components such as a laser cabinet/console, footswitch, and safety interlock, in addition to operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states surgical applications requiring the vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue. These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The device description details a laser system designed to deliver laser power for surgical procedures. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents or assays
- Diagnostic purposes based on in vitro testing
In summary, the INTERmedic Diode Laser Family is a surgical device used for treating tissue directly, not for performing diagnostic tests on samples outside the body.
N/A
Intended 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 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. Examples include:
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
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
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)
Product codes (comma separated list FDA assigned to the subject device)
GEX, GEI
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, external genitalia, bladder, prostate, Rectal and anal, liver, Thyriodectomy, Hepatobiliary, cardiac tissue, face, extremities, legs, Disc, meningiomas, Cervical, Ovarian, colon, esophageal, ear, nose, throat, larynx, vocal cord/fold, teeth, saphenous veins
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K042211, K040294, K031993, K050452, K052324, K041969, K041959, K050796, K050824, K032864, K002296, K021724, K000072, K003993, K020339
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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,
Sincerely yours,
Mark N. Melkerson, PhD
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
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:
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. Examples include:
> 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
3
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
5
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™ .
6
| Common Name | Medical Laser System (and Accessories) |
|---|---|
| Classification Name | Laser surgical instrument and accessories for use in general and |
| plastic surgery and in dermatology (21 CFR 878.4810) | |
| Product code: GEX Laser instrument, surgical, powered | |
| Subsequent product code: GEI Electrosurgical, cutting & | |
| coagulation & accessories | |
| Panel: 79 | |
| Class: 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
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
7
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.
8
Performance Data - Comparison Tables
| | INTERmedic
ENDO Laser | Dornier
K020339
Medilas |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 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 50-60Hz
220-240 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 invasive
endovenous treatment
of varicose veins (internal
and external saphenous
and collateral veins) of all
diameters under local
anesthesia, as well
as percutaneous treatments
of superficial
vascular lesions | Same |
| | INTERmedic
SURGICAL Laser incl. SR OFT 15 | BioLitec
K050824
Medilas |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 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 |
| Power
Requirements | 100-120 VAC 50-60Hz
220-240 VAC 50-60Hz | 100 - 240 VAC
50-60Hz |
| Operation
Mode | Continuous or pulsed | Continuous or
pulsed |
| Dimensions
(HxWxD) [inch] | 8x19x19 | 7x18x15 |
| Weight [lbs] | 35 | 33 |
| Indication for
use: | 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, including vascular lesions
and hair removal, General Surgery, Ophthalmology, Orthopedics,
Podiatry, Arthroscopy, Gynecology, Pulmonary Surgery, Neurosurgery,
Gastroenterology, Head/Neck/ENT and Radiology, Endovascular
coagulation, 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..
9
| 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 50-60Hz | |
| 220-240 VAC 50-60Hz | 100 - 240 VAC | |
| 50-60Hz | ||
| Operation Mode | Continuous or pulsed | Continuous or |
| pulsed | ||
| Dimensions | ||
| (HxWxD) [inch] | 8x19x19 | 7x18x15 |
| Weight [lbs] | 35 | 33 |
| Indication for use: | Neurosurgery: vaporization, incision, excision, ablation, and | |
| coagulation of peripheral soft tissue tumors, discectomy. | Same |
| | INTERmedic
ContrÂge and RF ContrÂge | Syneron
K052324,
K050452,K0507796
Polaris, 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 50-60Hz
220-240 VAC 50-60Hz | Standard 110VAC |
| Operation Mode | Continuous or pulsed | Continuous or
pulsed |
| 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, superficial
Benign vascular and pigment lesion treatment,
Skin rejuvenation, wrinkle reduction | Same |
The ContrÂge laser and RF unit is not an anti aging laser.
:
10
| | INTERmedic
SLP | Dornier
K050824, K021724, K020339
Medilas D Skin Pulse |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Wavelength [nm] | 810 | 940 |
| Peak Power | Up to 90W | 120W |
| Exposure time | 5 to 500ms (vascular mode)
50 to 1200ms (hair removal
mode) | 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 50-60Hz
220-240 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/or
removal of unwanted vascular
lesions and removal of
unwanted hair, pigment
lesions | Same |
| | INTERmedic
VARIUS and VAIRUS 1000 | Dornier
K050824, K021724, K020339
Medilas 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 50-60Hz
220-240 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, Vascular
treatment of leg and spider veins,
vascular and pigmented lesions
and skin treatments and rejuventation
cutaneous surgery: cutting, coagulation
and vaporization | Same | |
11
| | INTERmedic
ODONT | BioLitec
K050824
Ceralas |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| 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 |
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