PARASCAN SCANNING DEVICE

K964520 · Laserscope · GEX · Feb 10, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964520
• Device Name: PARASCAN SCANNING DEVICE
• Applicant: Laserscope
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO₂ soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; keratoses; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.

Device Story

ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece function as laser delivery accessories for CO2 laser systems. ParaScan provides automated scanning of laser beam; CBH-1 provides collimated beam delivery. Used by physicians in clinical settings for soft tissue surgery and dermatological resurfacing. Devices direct laser energy to target tissue to achieve ablation or excision. Benefits include precise tissue removal for cosmetic and therapeutic skin conditions. No complex software or AI algorithms described.

Clinical Evidence

Bench testing only; compliance with 21 CFR 1040.10 and 1040.11 for medical laser products.

Technological Characteristics

Scanning laser delivery system and collimated handpiece accessories for CO2 laser systems. Complies with 21 CFR 1040.10 and 1040.11. Mechanical beam delivery and scanning mechanism.

Indications for Use

Indicated for patients requiring CO2 laser soft tissue surgery, including treatment of wrinkles/rhytides, solar/actinic elastosis, keratoses, lentigos, laser skin resurfacing, laserbrasion, scar revision, warts, periorbital syringomas, epidermal nevi, rhinophyma, xanthelasma, actinic cheilitis, and debulking benign tumors.

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

• ParaScan Scanning Device (K955734)

Submission Summary (Full Text)

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k964520 FEB 10 1997

SUMMARY OF SAFETY AND EFFECTIVENESS
PARASCAN SCANNING DEVICE OR CBH-1 COLLIMATED BEAM
HANDPIECE FOR TREATMENT OF WRINKLES/RHYTIDES

REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT:
Lisa McGrath
Sr. Regulatory Affairs Specialist
Laserscope
3052 Orchard Parkway
San Jose, CA 95134-2011
[phone]
[phone] FAX

DEVICE TRADE NAME:
A. ParaScan™ Scanning Device
B. CBH-1 Collimated Beam Handpiece

DEVICE COMMON NAME:
A. Scanning Laser Delivery System
B. Collimated Handpiece

Note: Heraeus Surgical, Inc., including the LaserSonics product line, was acquired by Laserscope.

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SUMMARY OF SAFETY AND EFFECTIVENESS,
PAGE 2

DEVICE CLASSIFICATION:

CO₂ laser systems have been classified as Class II (79 GEX) medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, scanning laser delivery systems and handpiece accessories have not been classified.

PERFORMANCE STANDARDS:

The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

INDICATIONS FOR USE STATEMENT:

The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO₂ soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkles/rhytides; solar/actinic elastosis; keratoses; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.

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SUMMARY OF SAFETY AND EFFECTIVENESS,
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COMPARISON WITH PREDICATE DEVICE:

The ParaScan Scanning Device was determined substantially equivalent by FDA on February 13, 1996 for all previously cleared LaserSonics CO₂ soft tissue surgical applications (510(k)955734). The CBH-1 Collimated Beam Handpiece is equivalent to the ParaScan Scanning Device beam collimator and handpiece.

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