100W CERALAS D 980 LASER SYSTEM, MODEL D100
Device Facts
| Record ID | K050824 |
|---|---|
| Device Name | 100W CERALAS D 980 LASER SYSTEM, MODEL D100 |
| Applicant | Biolitec, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 10, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 device 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 and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.
Device Story
Ceralas D980 Model D100 is a 980 nm diode laser system; delivers laser energy to soft tissue via contact or non-contact modes; used in surgical procedures including endoscopic applications. System utilizes diode laser technology to perform incision, excision, vaporization, ablation, hemostasis, or coagulation. Operated by physicians in clinical/surgical settings. Output is laser light; healthcare providers use output to treat various soft tissue pathologies across multiple specialties; benefits include precise tissue management and reduced bleeding. Device features 100W maximum power; requires delivery fibers with 0.22 NA or greater. Used with ELVes Procedure Kit for endovenous vein occlusion.
Clinical Evidence
Bench testing only. Device complies with voluntary consensus standards including 21 C.F.R. §§ 1040.10 & 1040.11, ANSI/AAMI ES1, IEC 601-1, IEC 601-2-22, EN 60825-1, and ANSI/AAMI/ISO 10993-7.
Technological Characteristics
Diode laser system; 980 nm wavelength; 100W maximum power output; beam divergence 12.79; compatible with delivery fibers 0.22 NA or greater. Complies with IEC 601-1, IEC 601-2-22, and ISO 10993-7 standards.
Indications for Use
Indicated for incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in otolaryngology, arthroscopy, gastroenterology, general/plastic/podiatric surgery, dermatology, urology, gynecology, neurosurgery, pulmonary/cardiothoracic surgery, and dental applications. Also indicated for endovenous coagulation of the greater saphenous vein in patients with superficial vein reflux.
Regulatory Classification
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.
Predicate Devices
- 50W Ceralas D 980 Diode Laser System
- Ceralas F100 Nd:YAG Laser System
Submission Summary (Full Text)
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AUG 1 0 2005
K 050824
## 510(k) Summary 100W Ceralas Diode 980 nm Laser System (Model D100)
## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028 (413) 525-0600 Phone: Facsimile: (413) 525-0611
Contact Person: Carol J. Morello, V.M.D. Date prepared: March 31, 2005
## Name of Device and Name/Address of Sponsor
Ceralas D980 Diode Laser System, Model D100 ("100W Ceralas D980") Biolitec, Inc. 515 Shaker Road East Longmeadow, Massachusetts 01028
Classification Name Diode laser
## Predicate Devices
50W Ceralas D 980 Diode Laser System and Ceralas F100 Nd:YAG Laser System
## Intended Use/Indication 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 device 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 and 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 .
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K050824
- 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, Dermatologv, 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 homeostasis of capillary hemangioma .
- Excision, vaporization and hemostasis of abdominal tumors
- Excision, vaporization and hemostasis of rectal pathology
- Pilonidal cystectomy
- Herniorapphy
- Adhesiolysis
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K650824
- Parathyroidectomy .
- Laparoscopic cholecystectomy �
- Thyroidectomy .
- Resection of organs .
- Debridement of wounds .
- Phototcoagulation 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 homeostasis 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 .
### 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 .
### Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: homeostasis 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
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### 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.
KOS 0824
## 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 100W Ceralas D 980 is identical to the previously cleared 50W Ceralas D 980 except for four modifications. The 100W Ceralas D 980 has a maximum wattage of 100W, while the cleared 50W Ceralas D890 has a maximum wattage of 50W. In addition, the 100W Ceralas D980 has a beam divergence of 12.79, rather than 20.50, and therefore can be used with delivery fibers of smaller diameter (0.22 NA or greater) than those recommended for use with the 50W Ceralas D 980 (0.37 NA or greater). Finally, the 100W Ceralas D 980 contains additional diodes.
#### Performance Data
The device complies with the following voluntary consensus standards: 21 C.F.R. §§ 1040.10 & 1040.11; ANSI/AAMI ES1; IEC 601-1; IEC 601-2-22; EN 60825-1. and ANSI/AAMI/ISO 10993-7.
#### Substantial Equivalence
The 100W Ceralas D 980 has the same intended use and the same general and specific indications for use as the cleared 50W Ceralas D 980 Laser System. It also has the same intended use and some of the same general indications for use as the cleared 100W Ceralas Nd:YAG Laser System. The four minor technological modifications to the cleared 50W Ceralas D980 incorporated into the 100W Ceralas D 980 -- the increase in maximum wattage from 50W to 100W and in the number of diodes used to generate that wattage and the difference in beam divergence and recommended use with a smaller diameter delivery fiber -- do not raise any new questions of safety or effectiveness. Thus, the 100W Ceralas D 980 is substantially equivalent to its predicate devices.
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an abstract symbol, resembling a human figure embracing another, or possibly a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biolitec, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, LLP 555 Thirteenth Street, NW Washington, DC 20004-5910
Re: K050824
Trade/Device Name: Ceralas D 980 nm Diode Laser System, Model D100 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: June 28, 2005 Received: June 28, 2005
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of August 10, 2005.
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. 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 or any I 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) rms leter 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 yours,
elgmee.
Image /page/5/Picture/6 description: The image shows a stylized drawing of a human figure. The figure is drawn with a continuous line, forming a loop that represents the head and body. A small line extends from the head, possibly representing a nose or other facial feature. The drawing is simple and abstract, focusing on the overall shape and form of the human figure.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use Statement
510(k) Number (if known): K050824
Device Name: Ceralas D 980 nm Diode Laser System, Model D100
Indications for Use:
The device is intended for delivery of laser light to soft tissue in the conact and non The device is intented for delivery curres including via endoscopes. The 100W contact mode during surgical procedures in incision, excision, vaporization, Ceralas D900 is generally multures of soft tissue in ear, nose and throat and oral ablation, nemosvasio of coagamiss
surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, surgery (oldiaryngology), artiffestop.r.
dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery dermatology, prastic surgery, pourally, mores, 70
(peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental (perfpheral nervous of event), possion of the greater saphenous vein.
The device is specifically indicated for use as follows:
# Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Nose and Thision, 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 carci .
- Excision of polyps
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Division of General, Restorative
and Neurological Devices
Page 1 of
1 Number NOSD
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# 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 t
- Hemorrhoidectomy .
- Appendectomy .
- Debridement of decubitus ulcers .
- Hepatobiliary tumors .
- Mastectomy .
- Dermabrasion .
- Vaporization and homeostasis 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
- Phototcoagulation 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 homeostasis 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
of General, Restorative - US ( 1 ) 8 ) 1 2 3 mon 1 2 2 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8
K050824
Page 2 of 4
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#### Gynecology
cology
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 t
- Cervical conization t
- Menorrhagia .
#### Neurosurgery
Surgery
Vaporization, coagulation, excision, incision, ablation and hemostasis i v aportzation, cougalaton, cougalasis in conjunction with menigiomas
#### Cardiac Surgery
ac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation i of soft tissue in the pulmonary system. Examples include:
- Tracheobronchial malignancy or stricture .
- Benign and malignant pulmonary obstruction .
- Endoscopic pulmonary applications .
#### Dental Applications
II Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of tissue (incruding marginal arenotomy, biopsy, operculectomy, implant Iree giftgival). Treflectomy, fromotary, gingival troughing, crown lengthening, recovery, giffgivectority, gingropiason, granulation tissue, laser assisted flap nentostasis of donor of of 2018 at 6 the engineer incisions and draining of Surgery, debrident of areas in impressions, papillectomy, vestibuloplasy, absecuses, about for one of unerupted/partially erupted teeth, excision of resions, experplastic tissues, treatment of aphthous ulcers leukopiakia, removal of if porpiastic adiseased or inflamed soft tissue in the and bureandrypcket), pulpotomy, pulpotomy as an adjunct to root canal perfodonear posses, of bleaching materials for teeth whitening.
# y and light assiraclusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Its With Dupornoith 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)
Over-The-Counter Use
(21 C.F.R. 807 Subpart C)
AND/OR
Stop luoda
ision of General. Restorative .. Neurological Devices
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K050824
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#### (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER . .. . PAGE IF NEEDED) ستست = تته
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Sign-Off
Division of General, Restorative and Neurological Devices
logical Devices
510(k) Number K050824
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