OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER

Q: Who is the manufacturer of OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER?

Oberon GmbH Fiber Technologies filed the 510(k) submission for OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER (K140470).

Q: What is the FDA product code for OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER?

MED-Fibers, Inc. (K124003); Fiberoptic Fab (K120810).

Q: Who can help prepare an FDA 510(k) submission like OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K140470 · Oberon GmbH Fiber Technologies · GEX · Oct 15, 2014 · General, Plastic Surgery

Device Facts

Record ID	K140470
Device Name	OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
Applicant	Oberon GmbH Fiber Technologies
Product Code	GEX · General, Plastic Surgery
Decision Date	Oct 15, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The OBERON's, laser surgery fiber, is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 or compatible connectors. The OBERON, laser surgery fibers, Side Fire Laser surgery fibers and Dental Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fibers are intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers laser are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm - 2100nm) QBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Device Story

OBERON Laser Surgery Fiber is a fiber optic delivery system for laser light; transmits energy from cleared surgical lasers to soft tissue. Input: laser energy from external source (Argon, KTP, Ho:YAG, Nd:YAG, Diode). Output: laser light delivered to target tissue via contact or non-contact modes. Used in clinical settings (OR, endoscopy, cystoscopy) by physicians. Device features various distal tip configurations (flat, shaped, ball, round, side fire, radial) to facilitate specific surgical tasks like incision, ablation, or lithotripsy. Benefits include precise tissue interaction and versatility across multiple surgical specialties. No active electronic components; passive delivery system.

Clinical Evidence

No clinical data. Bench testing only; performance is established by comparison to legally marketed predicate devices.

Technological Characteristics

Passive fiber optic delivery system; silica glass core and cladding; protective sheath. Distal tips: flat, shaped, ball, round, side fire, radial. Connectors: SMA 905. Core diameters: 200-600 microns. Compatible with lasers 532nm-2100nm, 1-100W power. Sterile.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, vaporization, ablation, hemostasis, coagulation, dissection, resection) or lithotripsy. Applicable across general surgery, urology, gastroenterology, gynecology, vascular surgery, neurosurgery, plastic surgery, and ENT. Includes endovenous occlusion for superficial vein reflux and laser-assisted lipolysis. Used with compatible lasers (532nm-2100nm) in contact or non-contact modes.

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

MED-Fibers, Inc. (K124003)
Fiberoptic Fab (K120810)

Reference Devices

Laser Peripherals
Leoni
Lumenis
Cynosure
CermaOptec

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 15, 2014 OBERON GmbH Fiber Technologies % Dr. Armin Kaus MED-Fibers Incorporated 7404 West Detroit Street, Suite 140 Chandler, Arizona 85226 Re: K140470 Trade Name: OBERON Laser Surgery Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 12, 2014 Received: September 17, 2014 Dear Dr. Kaus: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 {1}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. > Sincerely yours, Binita S. Ashar -S 2014.10.15 15:29:03 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140470 Device Name OBERON Laser Surgery Fiber #### Indications for Use (Describe) The OBERON, laser surgery fiber, Side Fire laser surgery fibers are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm- 2100mm) OBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, 1.44YAG and Diode Lasers (532mm - 2100mm) with peak and continuous power from 1-100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510 (k) SUMMARY This 510(k) summary of safety and effectiveness is submitted in accordance with all of the requirements and follows Office of Device Evaluation guidance concerning the organization of a 510 (k) summary. ### OBERON 's Laser Surgery Fiber Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared OBERON GmbH Fiber Technologies Freiheitstrasse 120 15745 Wildau GERMANY Phone: +49 3375 21500-0 Fax: +49 3375 21500-10 ### Official Correspondent: Dr. Armin Kaus, Ph.D. 7404 W. Detroit Street, STE 140 Chandler, AZ 85226 Date Prepared: October 7, 2014 # Name of Device and Name of Sponsor OBERON Laser Surgery Fiber OBERON GmbH Fiber Technologies Freiheitsstrasse 120 15745 Wildau, GERMANY #### Common or Usual Name Nd:YAG-, Ho:YAG-, KTP- and Diode Laser -- Laser Fiber Delivery Systems # Classification Name Surgical Laser Accessory Regulation: 21 CFR §878.4810 Classification: II Product Code: GEX {4}------------------------------------------------ # Predicate Devices # 1 - Per 21 CFR 807.92 item (6) Summary with comparison values | | OBERON GmbH The fiber optic laser delivery devices are intended for delivery of laser light to soft tissue in the contact and noncontact mode during surgical procedures including via endoscopes and cystoscopes. The laser fiber is intended for use with any cleared surgical laser with an SMA 905 and compatible connectors. | MED-Fibers, Inc. K124003 The surgical fiber optic Laser delivery devices are intended for delivery of laser light to soft tissue in the contact and non con- tact mode during surgical procedures. The delivery device is intended for use with any surgical lasers with cleared laser with a compatible SMA 905 and compatible connectors. | Fiberoptic Fab K120810 The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The fiber optic delivery System is intended for use with any cleared surgical laser with an SMA 905. | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | | | | | Delivery Systems | | | | | Fiber | Flexible Fiber | Flexible Fiber | Flexible Fiber | | Material | Quartz Glass | Quartz Glass | Quartz Glass | | Core Diameter Proximal end | 200 - 600 micron SMA 905 and other compatible connectors | 200 - 1000 micron SMA 905 and other compatible connectors | 200 - 1000 micron SMA 905, SMA 906 and other compatible connectors | | Distal end | flat, shaped, ball, round, side fire, radial | flat, side fire and different shapes | flat, shaped, side fire | | Sterile (Yes/No) | Yes | Yes | Yes | | Max Recommended Power | Core Size: 200, 272 μ $20 W$ 365 μ $40 W$ 500 μ $100 W$ 400, 600 μ HPCS $30 W$ 600 µIRHCN $100 W$ 800 and 1000μ N/A | up to $45 W$ up to $60 W$ up to $100 W$ up to $40 W$ up to $100 W$ up to $200W$ | up to $45 W$ up to $113 W$ N/A N/A up to $100 W$ up to $200 W$ | | Indication for use | The laser delivery devices are intended for use in laser based surgical application to deliver the laser light to soft tissue during surgical applications. The delivery device is cleared for surgical lasers with compatible SMA 905 connectors. It is indicated for use in general surgery applications for incision, excision, vaporization, ablation and or coagulation. It is indicated for use in soft tissue procedures with cleared surgical laser systems with different wavelength. It is also indicated for use with cleared compatible laser systems in lithotripsy for the desired application. | The surgical fiber optic laser delivery devices, Endo-ENT fibers, side fire Fibers and Endo probes in the contact and non- contact mode during surgical procedures including via endoscopes and cysto-scopes. The surgical laser fiber is intended for use with any cleared surgical laser with an SMA 905 and compatible connectors. The surgical fibers are indicated for use in general surgery applications for incision, excision, vaporization, ablation, hemostasis, or coagulation. It is also indicated for use In open or closed endo- scopic applications where incision, excision, tissue dissection, excision of ex- ternal tumors and lesions complete or partial resection of intern. organs, It is also intended as an aid for otology procedures. In addition all surgical devices are intended for use in lithotripsy applications with cleared laser Systems. | The fiber optic laser delivery system is indicated for use in general surgery applications for incision, excision vaporization, ablation, hemostasis or coagulation, of soft tissue in a contact or non-contact mode. It is also indicated for use in open or closed endoscopic applications, where incision, excision, tissue dissection, excision of external tumors or lesions, complete or partial resection of internal organs, tumors or lesions, tissue vapo- rization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. Its intended to use for different cleared lasers with peak and continuous power from 1W - 200W. | {5}------------------------------------------------ # Intended Use / Indications of Use The OBERON's, laser surgery fiber, is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fiber is intended for use with any cleared surgical laser with a SMA 905 or compatible connectors. The OBERON, laser surgery fibers, Side Fire Laser surgery fibers and Dental Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The OBERON laser surgery fibers are intended for use with any cleared surgical laser with a SMA 905 connector. The OBERON laser surgery fibers laser are indicated for use in general surgery applications for: incision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact mode. It is also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm - 2100nm) QBERON laser surgery fiber is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm - 2100nm) with peak and continuous power from 1 - 100 Watt. OBERON laser surgery fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, {6}------------------------------------------------ vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. # Technical Characteristics OBERON's laser surgery fiber contains the same components and the same technological characteristics as the predicate devices. The fiber core and cladding or fibers with no cladding are made from silica which is the same material used in all the predicate devices. As mentioned, the optical fiber is made out of silica with a coaxially mounted protective sheath. The fiber distal tip can be several configurations and the fiber can be also used with hand pieces. OBERON's laser surgery fiber has no differences in technology and as such does not raise any new questions on safety or efficacy. Various core diameter sizes (200, 272, 365, 400, 550, 600microns) are offered. # Performance Data The performance of the OBERON's laser surgery fiber is well established and documented so no performance testing is included. The OBERON's laser surgery fiber delivery system operates in the same manner as the predicate devices and performs with no difference as compared with the predicate devices. # Substantial Equivalence The OBERON's laser surgery fibers are as safe and effective for the indications for use as the Laser Peripherals, Leoni, Lumenis, MED-Fibers, Cynosure, Fiberoptic Fabrications and CermaOptec fiber optic laser delivery systems previously cleared thus the OBERON's laser surgery fibers are substantially equivalent. | Signed: | | |------------------------|--| | Dr. Armin Kaus, Ph.D. | | | Official Correspondent | |

OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER

Device Facts

Indications for Use

Device Story

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Indications for Use

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Submission Summary (Full Text)

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OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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