# K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Nov 5, 1996 after 78 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
No predicates in its family tree.
397 later devices descend from it; 7 cite it directly.
0 of 398 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sharplan CO2 Lasers intended for use in ENT: named in the summary without a submission number
- (no number) ScalpelTEC, Inc. Myringotomy Safety Scalpel: named in the summary without a submission number

## Most influential descendants
- K991628: Modified LX-20 CO2 Laser System Family, LX-20SA (1999), 377 descendants of its own
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers (2003), 323 descendants of its own
- K031795: Reliant Laser System (2003), 318 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own

## Indications for use
They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.

Source page: https://510kreport.com/device/K963229
Methodology: https://510kreport.com/methodology