COHERENT ULTRAPULSE CO2 SURGICAL LASERS

K963339 · Coherent Medical Group · GEX · Jan 22, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963339
• Device Name: COHERENT ULTRAPULSE CO2 SURGICAL LASERS
• Applicant: Coherent Medical Group
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.

Device Story

Device delivers CO2 laser energy for soft tissue surgery; console/tower system with articulated arm, control panels, footswitch/handswitch, and various delivery accessories (handpieces, scanners, waveguides, micromanipulators). Operated by physicians in clinical/surgical settings. Laser energy ablates/vaporizes/excises/coagulates tissue; provides hemostasis and visualization. Clinical benefits include faster operative times, reduced bleeding, and improved cosmetic outcomes compared to cold steel surgery. Output is controlled by the surgeon to achieve precise tissue effects.

Clinical Evidence

Clinical evidence provided via literature review and studies. Studies demonstrate CO2 laser blepharoplasty is up to 33% faster than cold steel, provides superior hemostasis, and reduces ecchymosis/edema. Hair transplantation studies show faster operative times, reduced bleeding, and increased hair density compared to cold steel. Skin resurfacing studies demonstrate increased sub-epidermal collagen.

Technological Characteristics

CO2 laser system; articulated arm delivery; includes console, tower, control/display panels, footswitch/handswitch, remote control, and filtered air pump purge system. Accessories include handpieces, scanners, waveguides, micromanipulators, optical couplers, and laparoscopic adapters.

Indications for Use

Indicated for soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy, and general surgery (open/endoscopic). Specific applications include skin resurfacing (wrinkles, rhytids, furrows), blepharoplasty, hair transplantation recipient sites, wart removal, matrixectomy, and treatment of various lesions, tumors, and neoplasms.

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 ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K951812 & K912029)
• Coherent Family of Scanner Handpieces (K946304)
• Coherent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620)
• Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (K960521 & K955621)

Submission Summary (Full Text)

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# Attachment 15

510(k) Summary Statement for K963339 the
Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers

## I. General Information

**Submitter:** Coherent Medical Group
3270 West Bayshore Road
Palo Alto, CA 94303
**JAN 22 1997**

**Contact Person:** Anne C. Worden
**Summary Preparation Date:** Revised November 27, 1996

## II. Names

**Device Names:** Coherent ULTRAPULSE Family of Carbon Dioxide Surgical Lasers and Delivery Accessories.

**Primary Classification Name:** Laser Powered Surgical Instrument (and Accessories).

## III. Predicate Devices

- Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and Delivery Accessories (K951812 & K912029) marketed by Coherent Medical Group;
- Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K946304) marketed by Coherent Medical Group;
- Coherent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620) marketed by Coherent/Xanar
- Sharplan Carbon Dioxide SilkLaser with FeatherTouch and SilkTouch (510(k) cleared November 4, 1996 - K number unknown, K960521, & K955621)

## IV. Product Description

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (and its delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.

Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are comprised of the following main components:

- a laser console and tower;
- a counterbalanced articulated arm and delivery system;
- control and display panels;
- footswitch and handswitch delivery controls;
- a remote control unit;
- a filtered air pump purge system; and
- a variety of delivery device accessories (handpieces, scanners, waveguides, micromanipulators, optical couplers and laparoscopic adapters, and insufflation and purge gas systems).

510(k) Coherent ULTRAPULSE
Family of Carbon Dioxide Surgical Lasers
Attachment 15 - Page 1
Page Amended November 27, 1996

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# V. Indications for Use

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and the Delivery Accessories that are used with them to deliver light energy are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); arthroscopy (knee surgery); and open and endoscopic general surgery.

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use in specific surgical applications including:

## Dermatology & Plastic Surgery

- Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces) in the performance of laser skin resurfacing and laser derm-abrasion (using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces), and laser burn debridement.

- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery using the CPG UltraScan Handpiece or the TrueSpot family of collimated fixed and variable spot-sized handpieces for the treatment of wrinkles, rhytids, and furrows.

Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO₂ laser increases the amount of sub-epidermal collagen.

- Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas (including buccal hemangiomas), tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts).

## Dermatology, Plastic Surgery and General Surgery

- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.

Clinical studies¹,²,³,⁴,⁵,⁶ demonstrate that CO₂ laser blepharoplasty provides cosmetic results that are equivalent to cold steel blepharoplasty, is up to 33% faster than cold steel blepharoplasty, provides good hemostasis and visualization of the surgical field, and results in less ecchymosis, edema, and bruising when compared to cold steel.

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1. Morrow, D.; Morrow L. CO₂ Blepharoplasty: A Comparison with Cold-Steel Surgery J Dermatol Surg Oncol 1992; 18:307-313.
2. David, L. The Laser Approach to Blepharoplasty J Dermatol Surg Oncol 1988; 14:7:741-746.
3. David, L.; Sanders G. CO₂ Laser Blepharoplasty: A Comparison to Cold Steel and Electrocautery J Dermatol Surg Oncol 1987; 13:2:110-114.
4. Baker, S.; Muenzler, W.; Small, R.; Leonard, J. Carbon Dioxide Laser Blepharoplasty Ophthalmology 1984; 91:238-244.
5. David, L.; Abergel, R. CO₂ Laser Blepharoplasty Cosmetic Surgery of the Skin: Principles and Techniques, B.C. Decker, Philadelphia, PA, 1991, Chapter 15:295-300.
6. Glassberg, E.; Babapour, R.; Lask, G. Current Trends in Laser Blepharoplasty Dermatol Surg 1995; 21:1060-1063.

510(k) Coherent ULTRAPULSE
Family of Carbon Dioxide Surgical Lasers
Attachment 15 - Page 2
Page Amended November 27, 1996

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# V. Indications for Use - Continued

## Dermatology, Plastic Surgery and General Surgery - Continued

- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the creation of recipient sites for hair transplantation.

Clinical studies⁷, ⁸, ⁹, ¹⁰ demonstrate that the use of ULTRAPULSE CO₂ surgical lasers, as compared to cold steel, results in faster operative times, reduced bleeding, no compression of laser created sites (due to removal of scalp tissue vaporized from laser created sites), and greater hair density (due to removal of scalp tissue vaporized from laser created sites).

## Podiatry

- Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of verrucae vulgares (warts)
- Laser ablation, vaporization, and/or excision in podiatry for matrixectomy.

## Otorhinolaryngology (ENT)

- Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of choanal atresia, leukoplakia of larynx, nasal obstruction, adult and juvenile papillomatosis polyps, rhinophyma, and verrucae vulgares (warts).

## Gynecology

- Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of cervical intraepithelial neoplasia, condyloma acuminata, leukoplakia (vulvar dystrophies), and vulvar and vaginal intraepithelial neoplasia

## Neurosurgery

- Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of basal tumor-meningioma, posterior fossa tumors, peripheral neurectomy, and lipomas/large tumors.

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⁷. Unger, W. *Laser Hair Transplantation II* Dermatol Surg 1995; 21:759-765.

⁸. Fitzpatrick, R. *Laser Hair Transplantation - Tissue Effects of Laser Parameters* Dermatol Surg 1995; 21:1042-1046

⁹. Ho, C.; Nguyen, Q.; Lask, G.; Lowe, N. *Mini-Slit Graft Hair Transplantation Using the Ultrapulse Carbon Dioxide Laser Handpiece* Dermatol Surg 1995; 21:1056-1059.

¹⁰. Unger, W.; David, L. *Laser Hair Transplantation* J Dermatol Surg Oncol 1994; 20:515-521.

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510(k) Coherent ULTRAPULSE Family of Carbon Dioxide Surgical Lasers

Attachment 15 - Page 3 Page Amended November 27, 1996

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# VI. Rationale for Substantial Equivalence

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and their delivery device accessories share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K912029), the Coherent Family of Scanner Handpieces (K946304), the Coherent Xanar XA-50 Carbon Dioxide Surgical Laser (K853620), and to the $\mathrm{CO}_{2}$ SilkLaser with FeatherTouch and SilkTouch Flash Scanners, marketed by Sharplan Lasers, Inc (510(k) cleared November 4, 1996 - K number unknown, K960521, and K955621). In addition, clinical data demonstrated that the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective when indicated for use for additional specific applications in a variety of medical specialties.

# VII. Safety and Effectiveness Information

Clinical data was provided to demonstrate that the Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers are safe and effective, when indicated for use for specific applications in the medical specialties of dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); and general surgery.

# VIII. Conclusion

The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers were found to be substantially equivalent to similar currently marketed and predicate surgical laser devices. The Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers share the same indications for use, similar design features, and similar functional features as the currently marketed Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers and delivery devices, and are substantially equivalent to the Coherent Xanar XA-50 and the Sharplan SilkLaser (with FeatherTouch and SilkTouch Flash Scanners).

Clinical study results demonstrated Coherent ULTRAPULSE $\mathrm{CO}_{2}$ Surgical Lasers are safe and effective for use in a variety of specific indications for use in a variety of medical specialties including dermatology; plastic surgery; podiatry; neurosurgery; gynecology; otorhinolaryngology (ENT); and general surgery.

510(k) Coherent ULTRAPULSE
Family of Carbon Dioxide Surgical Lasers
Attachment 15 - Page 4
Page Amended November 27, 1996