← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K960032

# COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS (K960032)

_Coherent Medical Group · GEX · Apr 1, 1996 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960032

## Device Facts

- **Applicant:** Coherent Medical Group
- **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md)
- **Decision Date:** Apr 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4810
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic

## Intended Use

The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

## Device Story

VersaPulse Aesthetic Surgical Lasers deliver laser energy (532 nm, 1064 nm, 755 nm, 2940 nm) for soft tissue surgery. System includes laser console/tower, articulated arm, fiber port, control/display panels, footswitch/handswitch, and various delivery accessories (handpieces, scanners, epidermal cooling). Operated by clinicians in dermatology, plastic, or general surgery. Device transforms electrical energy into specific laser wavelengths to achieve photothermolysis, excision, incision, ablation, vaporization, or coagulation. Clinician uses control panel to set parameters; output delivered via handpiece to target tissue. Benefits include precise tissue interaction for aesthetic and surgical procedures.

## Clinical Evidence

In-vivo testing performed to demonstrate laser energy equivalence to currently marketed surgical lasers. Biocompatibility testing conducted for new delivery device materials contacting patient tissue. No clinical human trial data reported.

## Technological Characteristics

Laser-powered surgical instrument. Wavelengths: 532 nm, 1064 nm, 755 nm, 2940 nm. Components: laser console, articulated arm, fiber delivery, control/display panels, footswitch/handswitch, scanners, epidermal cooling. Design features: control system, laser tube configuration, active medium, cooling system. Biocompatible materials used in delivery accessories.

## Regulatory 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

- Laserscope Orion SL Series & KTP/532, KTP:YAG Surgical Lasers ([K941841](/device/K941841.md), [K933880](/device/K933880.md) & [K911830](/device/K911830.md))
- Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers ([K952636](/device/K952636.md), [K922935](/device/K922935.md) & [K922577](/device/K922577.md))
- Continuum Biomedical MedAlex 755 nm Surgical Lasers ([K935631](/device/K935631.md))
- Candela TL-1 Alexandrite Laser ([K944090](/device/K944090.md) & [K940173](/device/K940173.md))
- Pfizer/Premier Centauri & Pegasus 2940 nm Surgical Lasers ([K905802](/device/K905802.md) & [K904627](/device/K904627.md))
- Continuum Multilite Er:YAG (755 nm) Surgical Laser ([K933057](/device/K933057.md))
- Laserscope SmartScan Fiber Delivery Device ([K941841](/device/K941841.md))
- Candela 10 mm Circular Spot Laser Handpiece ([K950661](/device/K950661.md))
- Coherent Family of Scanner Handpieces ([K951812](/device/K951812.md) & [K946304](/device/K946304.md))
- Cyrus Chess Cool Laser Optics (CLO) Unit ([K934486](/device/K934486.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

K960032

APR - 1 1996

Attachment 27

510(k) Summary Statement for the

Coherent VersaPulse Aesthetic Surgical Lasers

# I. General Information

Submitter: Coherent Medical Group
3270 West Bayshore Road
Palo Alto, CA 94303

Contact Person: Anne C. Worden

Summary Preparation Date: December 29, 1995

# II. Names

Device Names: Coherent VersaPulse Aesthetic Surgical Lasers and Delivery Accessories.

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

# III. Predicate Devices

- Laserscope Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830)
- Continuum Biomedical Medlite 532 & 1064 nm Surgical Lasers (K952636, K922935 & K922577)
- Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631)
- Candela TL-1 Alexandrite Laser (K944090 & K940173)
- Pfizer/Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627)
- Continuum Multilite Er:YAG (755 nm) Surgical Laser (K933057)
- Laserscope SmartScan Fiber Delivery Device for use with Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830)
- Candela 10 mm Circular Spot Laser Handpiece (K950661)
- Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304)
- Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (577 nm and 585 nm), and KTP (532 nm) Surgical Lasers (K934486)

# IV. Product Description

The Coherent VersaPulse Aesthetic Surgical Lasers (and its delivery accessories) are intended to be used to deliver: frequency doubled, Q-switched frequency doubled, and Q-switched Nd:YAG; Q-switched Alexandrite:YAG laser energy for use in surgical applications requiring the photothermolysis (photocoagulation) of soft tissue; and Er:YAG laser energy for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

Coherent VersaPulse Aesthetic Surgical Lasers are comprised of the following main components:

510(k) Coherent VersaPulse Aesthetic Surgical Lasers

Attachment 27 - Page 1

{1}

- a laser console and tower;
- a counterbalanced articulated arm and delivery systems;
- a fiber port and delivery systems;
- control and display panels;
- footswitch and handswitch delivery controls;
- a remote control unit; and
- a variety of delivery device accessories (articulated arm and fiber handpieces, scanners, and epidermal cooling devices).

## V. Indications for Use

The Coherent VersaPulse Aesthetic Surgical Lasers and the Delivery Accessories that are used with them to deliver 532 nm, 1064 nm and 755 nm laser energy that are indicated for use in surgical applications requiring photothermolysis of soft tissue, and 2940 nm laser energy that is indicted for use in surgical applications requiring excision, incision, ablation, vaporization, and coagulation of soft tissue in medical specialties including: general and plastic surgery; and dermatology.

## VI. Rationale for Substantial Equivalence

The Coherent VersaPulse Aesthetic Surgical Lasers and their delivery device accessories share the same indications for use, similar design features (including control system, wavelengths, beam quality, laser tube 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 Laserscope Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841, K933880 & K911830), the Continuum Biomedical Medlite 532 nm & 1064 nm Surgical Lasers (K952636, K922935 & K922577), the Continuum Biomedical MedAlex 755 nm Surgical Lasers (K935631), the Candela TL-1 Alexandrite Surgical Lasers (K944090 & K940173), the Pfizer/Premier Centauri & Pegasus 2940 nm Surgical Lasers (K905802 & K904627), and the Continuum Multilite Er:YAG Surgical Laser (K933057), and to the Laserscope SmartScan Fiber Delivery Device for use with Orion SL Series & KTP/532, KTP:YAG Surgical Lasers (K941841), the Candela 10 mm Circular Spot Laser Handpiece (K950661), the Coherent Family of Scanner Handpieces for use with Coherent ULTRAPULSE Carbon Dioxide Surgical Lasers (K951812 & K946304), as well as the Cyrus Chess Cool Laser Optics (CLO) Unit for use with Argon (488/514 nm), Argon/Dye (577 nm and 585 nm), and KTP (532 nm) Surgical Lasers (K934486).

## VII. Safety and Effectiveness Information

In-vivo testing (was performed to demonstrate that the laser energy provided by the Coherent VersaPulse Aesthetic Surgical Lasers is equivalent to that provided by the currently marketed surgical lasers. Testing is performed to establish the biocompatibility of new delivery device materials that could potentially contact patient tissue.

510(k) Coherent VersaPulse Aesthetic Surgical Lasers
Attachment 27 - Page 2

{2}

# VIII. Conclusion

The Coherent VersaPulse Aesthetic Surgical Lasers were found to be substantially equivalent to similar currently marketed surgical laser devices. The Coherent VersaPulse Aesthetic Surgical Lasers share the same indications for use, similar design features, and similar functional features as the currently marketed Surgical Lasers and delivery devices. The physical test results demonstrated that the Coherent VersaPulse Aesthetic Surgical Lasers have acceptable performance characteristics.

510(k) Coherent VersaPulse Aesthetic Surgical Lasers
Attachment 27 - Page 3

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960032](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960032)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com