OmniGuide RFID Surgical Laser Fibers
Device Facts
| Record ID | K230819 |
|---|---|
| Device Name | OmniGuide RFID Surgical Laser Fibers |
| Applicant | Omni-Guide Holdings, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Apr 21, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.
Device Story
Single-use fiber optic delivery system; transmits laser energy from compatible surgical laser systems to surgical site. Input: laser light energy (500-2200nm) from external laser source. Transformation: light propagation through fused silica fiber core. Output: focused laser energy for tissue ablation, coagulation, incision, or vaporization. Used in OR/clinic by physicians. Connects to laser via SMA 905/906 or proprietary connectors. Provides clinicians with precise energy delivery for various soft/hard tissue procedures; benefits include controlled surgical intervention.
Clinical Evidence
Bench testing only. No clinical or animal data required. Testing included power/energy input vs. output, beam profile/homogeneity, high-power testing, bend radius, pull testing, and mechanical stability. Packaging and sterilization validation performed per ISO standards.
Technological Characteristics
Fused silica core; fused silica or fluoropolymer hard cladding; fluoropolymer buffer; nylon/polyimide/Teflon jacket. Numerical aperture 0.22-0.48. Wavelength range 500nm-2200nm. Power range 1-300 Watts. SMA 905/906 or proprietary connectors. Sterilization: Ethylene Oxide (EtO). Standards: ISO 11135-1, ISO 11607-1, ISO 10993 series, ISO 14971, ASTM F88, ASTM F2096, ASTM F1980.
Indications for Use
Indicated for use in all surgical specialties requiring laser ablation, coagulation, incision, excision, or vaporization of soft/hard tissue using compatible laser systems (500nm-2200nm). Intended for use by clinicians in open, laparoscopic, or endoscopic procedures.
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
- OmniGuide LISA Laser Family of Surgical Laser Fibers (K220189)
Related Devices
- K980156 — SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS · Surgical Laser Technologies, Inc. · Feb 27, 1998
- K124003 — MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE · Med-Fibers, Inc. · Jan 17, 2013
- K220189 — LISA Laser Surgical Fibers · Omni-Guide Holdings, Inc. · Apr 29, 2022
- K201171 — LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable · Leoni Fiber Optics, Inc. · Apr 2, 2021
- K250113 — neoLaser Laser Surgery Fibers · G.N.S Neolaser , Ltd. · Mar 13, 2025
Submission Summary (Full Text)
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April 21, 2023
Omni-Guide Holdings, Inc. Carlos Acosta Global Director Regulatory Affairs & Ouality Assurance 43 Manning Road Billerica, Massachusetts 01821
Re: K230819
Trade/Device Name: OmniGuide RFID Surgical Laser Fibers 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: March 17, 2023 Received: March 24, 2023
Dear Carlos Acosta:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black and appears to be centered. The background is a light blue color, with a faint watermark-like design.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K230819
Device Name OmniGuide PRIMA Surgical Laser fibers
### Indications for Use (Describe)
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500mm - 2200mm have received regulatory clearance.
Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are intended for use with any cleared surgical laser with an SMA 905 connector, or manufacturer specific connectors and adapters.
Type of Use (Select one or both, as applicable)
| <span style="font-family: Arial;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text surrounded by a blue circle.
## 008_510(k)_Summary
| Classification Name | Common Name | Trade Name/Proprietary Name |
|----------------------------------------------------------|----------------------------|---------------------------------------|
| Part 878 General and Plastic Surgery<br>21 CFR §874.4680 | Laser Instrument, Surgical | OmniGuide Prima Surgical Laser Fibers |
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of Omni Guide knowledge.
Omni-Guide Holdings, Inc. is submitting this 510(k) of equivalent OmniGuide Prima Surgical Laser Fibers equivalent to our predicate devices, LISA Laser Surgical Fibers and cleared under Omni-Guide Holdings, Inc. own 510(k) K220189. LightGuide Optics International Ltd., is our Contract Manufacturer (CMO), a CMO of equivalent fibers (reference FDA Establishment Registration & Device Listing ID# 3012669557: - Powered Laser Surgical Instrument - Slimline Endo Fibers; Slimline Endo SIS Fibers; Slimline EZ SIS Fiber; Slimline Fibers; Slimline GI SIS Fiber; Slimline SIS Fibers). The manufacturing process of OmniGuide Prima Surgical Laser Fibers and sterilization are the same process to current FDA fibers manufactured by LGO, as well as the predicate device LISA Laser Surgical Fibers.
OmniGuide Prima Family of Surgical Laser Fibers and the Primary Predicate Device, share the same intended use, indication for use, human factors, design, performance, materials, manufacturing, mechanical safety, biocompatibility, sterilization. There minor difference in the technological characteristics do not raise any questions of safety or performance data demonstrates the OmniGuide are as safe and effective as the listed predicate. OmniGuide Prima Surgical Laser Fibers are substantially equivalent to its predicate device.
| Submitter: | Omni-Guide Holdings, Inc.<br>43 Manning Drive<br>Billerica, MA 01821 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carlos O. Acosta<br>Phone: 617-551-4400 Ext. 563<br>Fax: 888-490-6020 |
| Date of<br>Preparation: | February 22, 2023 |
| Type of 510(k)<br>Submission: | Special |
| Device<br>Identification: | Device Name and Classification 807.92(a)(2):<br>Trade Name: OmniGuide Prima Surgical Laser Fibers<br>Classification Name: Laser surgical instrument for use in general and plastic surgery and in<br>dermatology |
| Regulatory<br>Class: | II |
| Product Code: | GEX |
| Panel<br>Classification | General and Plastic Surgery (21 CFR §878.4810) |
| Predicate<br>Device: | Primary Predicate Device:<br>OmniGuide LISA Laser Family of Surgical Laser Fibers<br>Delivery Device 510(k) = K220189 |
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Image /page/4/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical an OmniGuide Company", and the third logo is for "LISA Laser Products an OmniGuide Company". All three logos have a similar design, with the company name in gray text and a blue circle around the name.
| Device<br>Description: | Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality<br>surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not<br>limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application<br>for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this<br>510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific<br>RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)]. | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------|
| Intended<br>Use:<br>Indications<br>For Use: | Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which<br>compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance.<br>Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical<br>laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters | | | |
| Substantial | | Comparison Table: Subject vs. Primary Predicate Devices | | |
| Equivalence<br>Comparison<br>Table | Characteristic | Subject Device<br>OmniGuide Prima Surgical Laser Fibers | Primary Predicate, OmniGuide LISA<br>Laser Surgical Fibers, K220189 | Equivalence |
| | 510(k) Number | Pending | K220189 | N/A |
| | Product Code | GEX | GEX | Same/<br>Equivalent |
| | Regulation<br>Number | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| | Regulation Name | Laser surgical instrument for use in general<br>and plastic surgery and in dermatology | Laser surgical instrument for use in general<br>and plastic surgery and in dermatology | Same/equivalent |
| | Components | Connector configurations offered suitable to<br>multiple laser platforms | Connector configurations offered suitable to<br>multiple laser platforms | Same/Equivalent |
| | Technological<br>characteristics | High OH or Low OH silica material w/low<br>attenuation of light wavelengths between<br>532nm - 2100nm | High OH or Low OH silica material w/low<br>attenuation of light wavelengths between<br>532nm - 2100nm | Same/Equivalent |
| | Silica/Silica<br>fibers/hard clad<br>fibers | Fiber having a Numerical<br>Aperture (NA) between 0.22 - 0.48 | Fiber having a Numerical<br>Aperture (NA) between 0.22 - 0.48 | Same/Equivalent |
| | Fiber distal tip | Multiple configurations of distal tips<br>offered to provide the most suitable<br>performance for the application | Multiple configurations of distal tips<br>offered to provide the most suitable<br>performance for the application | Same/Equivalent |
| | Used with<br>attachments | Core diameters are offered in a range of<br>sizes suitable to user needs | Core diameters are offered in a range of<br>sizes suitable to user needs | Same/Equivalent |
| Intended Use | | | Same/Equivalent | |
| Indication for Use | Omni-Guide Holdings, Inc. single-use<br>OmniGuide PRIMA Surgical Laser fibers are<br>indicated for use in all surgical specialties in<br>which compatible laser systems with<br>operational wavelengths between 500nm -<br>2200nm have received regulatory clearance.<br>Omni-Guide Holdings, Inc. single-use<br>OmniGuide PRIMA Surgical Laser fibers<br>devices are intended for use with any<br>cleared surgical laser with an SMA 905<br>connector, SMA 906 connector, or<br>manufacturer specific connectors and<br>adapters. | OmniGuide LISA Laser Surgical Fibers are<br>intended for use with any cleared surgical<br>laser with an SMA 905 connector, SMA<br>906 connectors, or manufacturer specific<br>connectors and adaptors<br>OmniGuide LISA Laser Surgical Fibers are<br>indicated for use in all surgical specialties<br>in which compatible laser systems with<br>operational wavelengths between 500nm -<br>2200nm have received regulatory<br>clearance. | Same/Equivalent | |
| Connectors | SMA 905 connector, SMA 906 connector,<br>or manufacturer specific connectors and<br>adaptors | SMA 905 connector, SMA 906 connector,<br>or manufacturer specific connectors and<br>adaptors | Same/Equivalent | |
| Fiber<br>Construction | Core - Fused Silica<br>Clad - Fused Silica or Fluoropolymer Hard<br>Cladding<br>Buffer - Fluoropolymer<br>Hard Cladding or Silicone Acrylate Jacket -<br>Nylon, Polyimide, or Teflon | Core - Fused Silica<br>Clad - Fused Silica or Fluoropolymer Hard<br>Cladding<br>Buffer - Fluoropolymer<br>Hard Cladding or Silicone Acrylate Jacket -<br>Nylon, Polyimide, or Teflon | Same/Equivalent | |
| Fiber Numerical<br>Aperture | Fiber having a numerical Aperture (NA)<br>between 0.22-048 | Fiber having a Numerical Aperture (NA)<br>between0.22-048 | Same/Equivalent | |
| Peak and<br>Continuous<br>Wave lengths | 500nm-2200nm | 500nm-2200nm | Same/Equivalent | |
| Power Ranges | 1-300 Watts | 1-300 Watts | Same/Equivalent | |
| Diameter | Core diameters are offered in a range of<br>sizes suitable to user needs | Core diameters are offered in a range of<br>sizes suitable to user needs | Same/Equivalent | |
| Fiber Distal Tip | Multiple configurations of distal tips offered<br>to provide the most suitable performance for<br>the application | Multiple configurations of distal tips<br>offered to provide the most suitable<br>performance for the application | Same/Equivalent | |
| Compatibility<br>with surgical laser<br>systems | Fibers are compatible with any cleared laser<br>system with an appropriate connection<br>system | Fibers are compatible with any cleared laser<br>system with an appropriate connection<br>system | Same/Equivalent | |
| Sterilization | EtO | EtO | Same/Equivalent | |
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
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Image /page/5/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, with the word "OmniGuide" in a sans-serif font above the word "Surgical". The second logo is for Domain Surgical, with the word "Domain" in a sans-serif font above the word "Surgical". The third logo is for LISAL Pro, with the word "LISAL" in a sans-serif font above the word "Pro". All three logos have a blue circle around the words.
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Image /page/6/Picture/0 description: The image shows three logos. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a blue circle around the name of the company.
Omni-Guide Holdings, Inc.
43 Manning Road
Billerica, MA 01821 web omni-guide.com
office 617.551.4400
fax 888.490.6020
Confidential
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Image /page/7/Picture/0 description: The image shows three logos. The first logo is for "OmniGuide Surgical", the second logo is for "Domain Surgical An OmniGuide Company", and the third logo is for "LISALaser Products An OmniGuide Company". All three logos have a similar design, with the company name inside of a double-lined circle.
| Non-Clinical<br>Performance<br>Data: | Bench testing (see Section 21) on the subject device has shown the device to perform as intended<br>with the same technological principle, fit, form, function, method of operating, including but not<br>limited to the listed date below. The subject device is substantially equivalent to the predicate<br>device and reference devices in the following attributes: | | | | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--|--------------------------------------------------------------------------------------------------------|--|
| | ➤ Indications for Use<br>➤ Intended Use<br>➤ Sterilization Technique<br>➤ Performance Characteristics<br>➤ Energy used and delivered | | ➤ Design<br>➤ Materials<br>➤ Packaging<br>➤ Shelf-Life<br>➤ Safety | | ➤ Manufacturing<br>➤ Clinical setting<br>➤ Mechanism Action<br>➤ Anatomical Site<br>➤ Biocompatibility | |
| Performance<br>Testing<br>Summary | The performance test reports focus on the key features of the fiber. These included the following<br>testing (depending on need):<br>1. Power & Energy input versus output<br>2. Homogeneity of output light (spot check, beam profile)<br>3. High-power testing<br>4. Bend radius testing<br>5. Pull testing<br>6. Feature specific testing was conducted to demonstrate equivalence to the predicate device and<br>reference devices: safety, performance, integrity, stability, transport, label integrity, packaging of<br>sterilized fibers. Reference section 21 for the following tests: Performance test of Prima 150 laser<br>fiber on RevoLix HTL; Performance test of Prima 1000 laser fiber on RevoLix HTL; Performance<br>test of PrimaSidefire laser fiber on RevoLix HTL; Test of mechanical stability of Prima 150 micron<br>laser fiber, Test of mechanical stability of Prima 1000 micron laser fiber, and Test of mechanical<br>stability of Prima 550 micron laser fiber,<br>Additional Feature testing conducted in the predicate Device LISA Laser Surgical Fiber K220189.<br>Much of the testing performed was based on a specific feature approach. Those features indicated in<br>K220189 performance testing were 1) Scatter Free Fiber, 2) Expanded transmission of laser<br>wavelength/energy, and 3) distal tip configuration, 4 Nav Tip tested for ability to traverse deflected<br>endoscope. These test reports show the features identified are proven to be safe and effective. Other<br>reports are similar in that they indicate passed testing of specific features or overall products | | | | | |
| Animal Testing | This product category does not require animal testing. | | | | | |
| Clinical<br>Performance<br>Data: | This product category does not require clinical testing. | | | | | |
| Compliance to<br>Standards | Document<br>Number | Title | | | | |
| | ISO 11135-1 | Sterilization of Health Care Products - Ethylene Oxide - Requirements for<br>the development, validation and routine control of a sterilization process for<br>medical devices | | | | |
| | ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements<br>for materials, sterile barrier systems and packaging systems | | | | |
| | ISO 10993-1 | Biological Evaluation of Medical Devices - Part 1: Evaluation and testing | | | | |
| | ISO 10993-5 | Biological Evaluation of Medical Devices - Part 5: Tests for in vitro<br>cytotoxicity | | | | |
| | ISO 10993-7 | Biological Evaluation of Medical Devices - Part 7: Tests for Ethylene<br>Oxide Sterilization Residuals | | | | |
| | ISO 10993-10 | Biological Evaluation of Medical Devices – Part 5: Tests for Irritation and<br>Skin Sensitization | | | | |
| | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 5: Tests for Systemic | | | | |
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Image /page/8/Picture/0 description: The image shows three logos for different surgical companies. The first logo is for OmniGuide Surgical, the second logo is for Domain Surgical, and the third logo is for LISA Laser Products. All three logos have a similar design, with a blue circle around the company name. The text below the company name indicates that LISA Laser Products and Domain Surgical are OmniGuide companies.
| ISO 14971 | Medical devices -- Application of Risk Management to Medical Devices |
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