(8 days)
Not Found
No
The summary describes a laser device for surgical procedures and does not mention any AI or ML capabilities.
Yes
Explanation: The device is intended for surgical procedures, including incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue across various medical specialties, which are all therapeutic interventions.
No
Explanation: The device is intended for surgical procedures such as incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue. It is a therapeutic device, not a diagnostic one.
No
The device is described as a laser light delivery system for surgical procedures, indicating it is a hardware device that emits laser light. The description of its intended use across various surgical specialties further supports this. There is no mention of the device being solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and indications for this device clearly describe its use for directly treating soft tissue within the human body through surgical procedures using laser light.
- The device description and intended use focus on surgical intervention. The actions described (incision, excision, vaporization, ablation, hemostasis, coagulation, etc.) are all direct surgical procedures performed on living tissue.
- There is no mention of analyzing biological samples. The text does not describe the device being used to test blood, urine, tissue samples, or any other specimen taken from the body.
Therefore, this device is a surgical laser system intended for direct treatment of soft tissue, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat.
- Excision and vaporization of vocal cord nodules and polyps.
- Incision and excision of carcinoma in situ.
- Ablation and vaporization of hyperkeratosis.
- Excision of carcinoma of the larynx.
- Laryngeal papillomectomy.
- Excision and vaporization of herpes simplex I and II
- Neck dissection.
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy.
- Synovectomy.
- Chondromalacia.
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding.
- Excision and vaporization of colorectal carcinoma.
- Excision of polyps.
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Liver resection.
- Excision of cutaneous lesions.
- Hemorrhoidectomy.
- Appendectomy.
- Debridement of decubitus ulcers.
- Hepatobiliary tumors.
- Mastectomy.
- Dermabrasion.
- Vaporization and hemostasis of capillary hemangioma.
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology.
- Pilonidal cystectomy
- Herniorapphy.
- Adhesiolysis.
- Parathyroidectomy.
- Laparoscopic cholecystectomy.
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities.
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors.
- Release of urethral stricture.
- Removal of bladder neck obstruction.
- Excision and vaporization of condyloma.
- Lesions of external genitalia.
- Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation.
- Excision or vaporization of condylomata acuminate.
- Vaporization of cervical intraepithelial neoplasia.
- Cervical conization
- Menorrhagia
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture.
- Benign and malignant pulmonary obstruction.
- Endoscopic pulmonary applications.
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, ear, nose, throat, oral cavity, joint tissues, upper and lower gastrointestinal tracts, skin, abdominal, rectal, fat, muscle tissue, urological tissues, prostate, gynecological tissue, cervical, soft tissue (neuro), cardiac tissue, soft tissue in the pulmonary system, tracheobronchial, intraoral soft tissues, extraoral soft tissues (including marginal and interdental gingival and epithelial lining of free gingival), Greater Saphenous Vein (GSV) of the thigh
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)
Performance testing of the Ceralas D100 demonstrates no significant difference as compared to the cleared Ceralas D100 device (K050824). Thus, the performance and safety testing obtained for the cleared Ceralas D100 is fully applicable to the Ceralas D100.
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.
Biolitec's 100W Ceralas D 980nm Diode Laser (K050824), INTERmedic Diode Laser Family 890nm and 980nm (K053540), Laserscope Lyra GTM Series Surgical Laser System (K010284)
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
K07/295
510(k) SUMMARY
MAY 16 2007
Biolitec Inc.'s 100W Ceralas Diode 980nm Laser System (Model D100)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson 555 13th Street NW Washington DC 20004
202 637-5794 Phone: Facsimile: (202) 637-5910
Jonathan S. Kahan Contact Person:
Date Prepared: May 16, 2007
Name of Device and Name/Address of Sponsor
100W Ceralas D 980nm Diode Laser (Model D100)
Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028
Common or Usual Name
Diode Laser
Classification Name
Laser, Surgical Diode Laser System
Predicate Devices
Biolitec's 100W Ceralas D 980nm Diode Laser (K050824)
INTERmedic Diode Laser Family 890nm and 980nm (K053540)
Laserscope Lyra GTM Series Surgical Laser System (K010284)
Intended Use / Indications for Use
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via
1
endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat .
- Excision and vaporization of vocal cord nodules and polyps .
- Incision and excision of carcinoma in situ .
- Ablation and vaporization of hyperkeratosis .
- Excision of carcinoma of the larynx .
- Laryngeal papillomectomy .
- Excision and vaporization of herpes simplex I and II ●
- Neck dissection .
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy .
- Synovectomv .
- Chondromalacia .
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding .
- Excision and vaporization of colorectal carcinoma .
- . Excision of polyps
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- · Matrixectomy
- Excision of neuromas .
- Excision of periungual and subungual warts .
- . Excision of plantar warts
- Excision of keloids .
2
- Liver resection .
- Excision of cutaneous lesions .
- Hemorrhoidectomy .
- Appendectomy .
- Debridement of decubitus ulcers .
- Hepatobiliary tumors .
- . Mastectomy
- Dermabrasion ●
- Vaporization and hemostasis of capillary hemangioma .
- Excision, vaporization and hemostasis of abdominal . tumors
- Excision, vaporization and hemostasis of rectal pathology .
- Pilonidal cystectomy ●
- Herniorapphy .
- Adhesiolysis .
- Parathyroidectomy .
- Laparoscopic cholecystectomy .
- Thyroidectomy .
- Resection of organs .
- Debridement of wounds .
- Photocoagulation of teleangectasia of the legs and face .
- Photocoagulation of vascular lesions of the face and . extremities
- Endovascular coagulation of the greater saphenous vein of . the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities .
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors .
- Release of urethral stricture .
- Removal of bladder neck obstruction .
- Excision and vaporization of condyloma .
- Lesions of external genitalia .
- Vaporization of the prostate to treat benign prostatic . hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation ●
- Excision or vaporization of condylomata acuminata .
- Vaporization of cervical intraepithelial neoplasia .
- . Cervical conization
- Menorrhagia .
3
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonarv Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications .
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Technological Characteristics
The Ceralas D100 for vaporization of the prostate to treat BPH has the same technological characteristics as the cleared Ceralas D100 and substantially similar technological characteristics as compared to the INTERmedic Diode Laser.
Performance Data
Performance testing of the Ceralas D100 demonstrates no significant difference as compared to the cleared Ceralas D100 device (K050824). Thus, the performance and safety testing obtained for the cleared Ceralas D100 is fully applicable to the Ceralas D100.
4
Substantial Equivalence
The Ceralas D100 is as safe and effective as Biolitec's 100W Ceralas D 980nm Diode Laser (K050824) and INTERmedic's Diode Laser Family 890nm and 980nm (K053540). The Ceralas D100 has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas D100 and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Ceralas D100 is as safe and effective as the predicate devices. Thus, the Ceralas D100 is substantially equivalent.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three overlapping wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FFB 2 1 2008
Biolitec. Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, DC 20004
Re: K071295
Trade/Device Name: 100W Ceralas D 980nm Diode Laser (Model D100) Regulation Number: 21 CFR 8878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: May 8, 2007 Received: May 8, 2007
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of May 16, 2007.
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.
6
Page 2 - Mr. Jonathan S. Kahan
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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html
Sincerely vours.
Image /page/6/Picture/5 description: The image shows a handwritten symbol that appears to be a stylized letter or character. It features a large, rounded shape resembling a cursive 'R' or a loop, with a smaller, angled stroke extending from the upper right portion of the loop. The symbol is drawn in black ink or a dark color, set against a white background, giving it a clear and simple appearance.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number (if known): K071295
100W Ceralas D 980nm Diode Laser (Model D100) Device Name:
Indications for Use:
The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The 100W Ceralas D980 is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
The device is specifically indicated for use as follows:
Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:
- Removal of benign lesions from the ear, nose and throat .
- Excision and vaporization of vocal cord nodules and polyps ●
- Incision and excision of carcinoma in situ .
- . Ablation and vaporization of hyperkeratosis
- Excision of carcinoma of the larynx .
- Laryngeal papillomectomy .
- Excision and vaporization of herpes simplex I and II .
- Neck dissection
Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:
- Menisectomy .
- Synovectomy .
- Chondromalacia .
8
Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:
- Hemostasis of upper and lower GI bleeding .
- Excision and vaporization of colorectal carcinoma .
- Excision of polyps .
General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy ●
- Excision of neuromas ●
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids ◆
- Liver resection .
- Excision of cutaneous lesions .
- Hemorrhoidectomy .
- Appendectomy .
- Debridement of decubitus ulcers .
- Hepatobiliary tumors .
- Mastectomy .
- Dermabrasion .
- Vaporization and hemostasis of capillary hemangioma .
- Excision, vaporization and hemostasis of abdominal tumors ●
- Excision, vaporization and hemostasis of rectal pathology .
- Pilonidal cystectomy ●
- Herniorapphy .
- Adhesiolysis .
- Parathyroidectomy .
- Laparoscopic cholecystectomy .
- Thyroidectomy
- Resection of organs
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities .
9
Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:
- Vaporization of urethral tumors .
- Release of urethral stricture .
- Removal of bladder neck obstruction .
- Excision and vaporization of condyloma .
- Lesions of external genitalia .
- Vaporization of the prostate to treat benign prostatic . hyperplasia (BPH)
Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:
- Endometrial ablation .
- Excision or vaporization of condylomata acuminate .
- Vaporization of cervical intraepithelial neoplasia .
- Cervical conization ●
- Menorrhagia ●
Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas
Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.
Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications .
Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy,
10
gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K071295 |
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