# K980398: Kaplan Pendulaser 115 Surgical Laser with Optoscan II

- Pathway: 510(k) (Traditional)
- Applicant: Optomedic Medical Technologies, Ltd.
- Decided: Sep 22, 1998 after 232 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K936109 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963339: Coherent Ultrapulse CO2 Surgical Lasers, Coherent Medical Group (1997) Summary page 1.
- K860087: Sharplan Model 1020 CO2 Surgical Laser System, Sharplan Lasers, Inc. (1986) Summary page 1.
- K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K961935: Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 1.
- K950313: Kaplan Pendulaser 115 - a 15W CO2 Surgical Laser, Optomedic Medical Technologies, Ltd. (1995) Summary page 1.
- K964684: Softouch, Sahar Technologies, Inc. (1997) Summary page 1.

## Indications for use
The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is indicated for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: Dermatology, Plastic Surgery, Podiatry, Neurosurgery, Gynecology, Otorhinolaryngology, Arthroscopy (knee), Open & Endoscopic General Surgery. The Kaplan PenduLaser 115 Surgical Laser with OptoScan II Scanner accessory is safe and effective when indicated for use in specific surgical applications including: Ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of laser skin resurfacing, laser derm-abrasion, and laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids, and furrows. 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). Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.

Source page: https://510kreport.com/device/K980398
Methodology: https://510kreport.com/methodology