MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
Device Facts
| Record ID | K980685 |
|---|---|
| Device Name | MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS |
| Applicant | Lumenis, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | May 20, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and the delivery systems and accessories that are used with them to deliver Ho:YAG and Ho:YAG/Nd:YAG laser energy are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: urology; urinary lithotripsy; arthroscopy; discectomy; endonasal Ho:YAG surgery; gynecological surgery; and general surgery; and urology; general surgery; gastroenterology; thoracic and pulmonary Nd:YAG surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy. The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH).
Device Story
Surgical laser system delivering Ho:YAG and Nd:YAG energy for soft tissue ablation, vaporization, excision, incision, and coagulation. System includes laser console, fiber port, control/display panels, footswitch/handswitch, remote control, and various delivery accessories. Operated by physicians in clinical settings (OR, endoscopic suites). Laser energy delivered via fiber-optic accessories to target tissue; thermal energy effects tissue removal or coagulation. Used for urological, gynecological, general, ENT, and orthopedic procedures. Specifically indicated for HoLRP to treat BPH. Clinical benefit derived from precise tissue resection and coagulation capabilities.
Clinical Evidence
Clinical study results provided to demonstrate safety and effectiveness for endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH).
Technological Characteristics
Laser-powered surgical instrument. Features Ho:YAG and Nd:YAG wavelengths. Includes laser console, fiber delivery port, control/display panels, footswitch/handswitch, and remote control. System parameters include adjustable power, repetition rate, energy, and spot sizes. Cooling system integrated. Design features consistent with predicate VersaPulse Select series.
Indications for Use
Indicated for patients with benign prostatic hypertrophy (BPH) requiring endoscopic holmium laser resection of the prostate (HoLRP).
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
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K933318)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K932981)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K923575)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K914991)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K914136)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K910037)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K902990)
- Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K895518)
Related Devices
- K954597 — RIGHT ANGLE LASER FIBERS · Trimedyne, Inc. · Mar 11, 1996
- K970422 — RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS · Trimedyne, Inc. · Apr 21, 1997
- K092735 — GREENLIGHT XPS LASER SYSTEM · American Medical Systems, Inc. · Nov 9, 2009
- K972548 — SLT CL MD CONTACT LASER SYSTEM · Surgical Laser Technologies, Inc. · Apr 21, 1998
- K112013 — EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER · Biolitec, Inc. · Jan 13, 2012
Submission Summary (Full Text)
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K980485
# Attachment 10 510(k) Summary Statement for the Modified Coherent VersaPulse Select Ho:YAG Single Wavelength and Ho:YAG/Nd:YAG Dual Wavelength Surgical Lasers
#### I. General Information
Coherent Medical Group Submitter: 3270 West Bayshore Road Palo Alto, CA 94303 Anne C. Worden Contact Person: February 20, 1998 Summary Preparation Date:
- II. Names
Device Names: Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Accessories.
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories).
#### III. Predicate Devices
• Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518)
### IV. Product Description
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are comprised of the following main components:
- · a laser console
- · a fiber port (for delivery systems)
- · control and display panels
- · footswitch and handswitch delivery controls
- · a remote control unit
- · a variety of delivery device systems and accessories
#### V. Indications for Use
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and the delivery systems and accessories that are used with them to deliver Ho:YAG and Ho:YAG/Nd:YAG laser energy are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including:
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- urology; urinary lithotripsy; arthroscopy; discectomy; endonasal · Ho:YAG surgery; gynecological surgery; and general surgery; and
- urology; general surgery; gastroenterology; thoracic and pulmonary • Nd:YAG surgery; ENT surgery; podiatry; orthopaedics; and with limited indications in gynecology; neurosurgery; ophthalmology; and lumbar discectomy.
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH).
### VI. Rationale for Substantial Equivalence
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and their delivery device accessories share the same indications for use, similar design features (including control system, wavelengths, beam quality, laser configuration, active medium, cooling system, and controls and displays), functional features (including power, repetition rate, energy, spot sizes and treatment areas), and therefore are substantially equivalent to the Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and their delivery device accessories (K960413, K933318, K932981, K923575, K914991, K914136, K910037, K902990, and K895518).
## VII. Safety and Effectiveness Information
Clinical data was provided to demonstrate that the Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective, when indicated for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
## VIII. Conclusion
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers were found to be substantially equivalent to the currently marketed and predicate VersaPulse Select surgical lasers. The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers share the same indications for use, design features, and similar functional features as, and thus are substantially equivalent to the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers.
Clinical study results demonstrated that the modified and predicate Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are safe and effective for use in endoscopic holmium laser resection of the prostate (HoLRP) for the treatment of benign prostatic hypertrophy (BPH) in the medical specialty of urology.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1998
Ms. Anne C. Worden ·Sr. Manager, Regulatory Affairs Coherent® Medical Group 3270 West Bayshore Road Post Office Box 10122 94303-0810 Palo Alto, California
K980685 Re: Modified Versapulse Select Ho:YAG/ND:YAG Trade Name: Lasers Regulatory Class: II GEX Product Code: February 20, 1998 Dated: Received: February 23, 1998
Dear Ms. Worden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Rand and Drug Administration (FDA) will verify such assamptions. Failure to comply with the GMP regulation may result in regulatery In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Worden
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Witton, Ph.D.
a M. Witten, Ph.D., M.D. Celi Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known):_____________________________________________________________________________________________________________________________________________________ Device Name : Modified Coherent VersaPulse Select Single Wavelength Ho:YAG & Dual Wavelength Ho:YAG/Nd:YAG Surgical Lasers & Delivery Devices
Indications For Use:
The modified and the currently marketed Coherent VersaPulse Select Single Wavelengt
(Ho:YAG) and Dual Wavelength (Ho:YAC/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for tr ign prostatic hypertrophy (BPH).
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980685 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use (Optional Format 1-2-96) |
tication, 510(k) for the Modifi Ise Select Ho:YAG and Ho:YAG/Nd:YAG Surgical Lasers Attachment
