510(k) · Cleared
ClearedKaplan Pendulaser 115 Surgical Laser with Optoscan II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Optomedic Medical Technologies, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Sep 22, 1998 as substantially equivalent to K963339 (Coherent Medical Group, 1997) and 5 other predicates after a 232-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 22, 1998
- Review
- 232 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K936109 (1994). 15 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 2 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 1 generation backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- This deviceK980398 Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −2 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −1 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| 0 (this device) | K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | Optomedic Medical Technologies, Ltd. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…EVICES The Kaplan PendulLaser 115 CO2 Surgical Laser with OptoScan |l Scanner Accessory is substantially equivalent to the Coherent UltraPulse 5000 system cleared under K963339 and to the Sharplan SilkTouch/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combi… | 1997 |
| * | K860087 | Sharplan Model 1020 CO2 Surgical Laser SystemSummary page 1…canner Accessory is substantially equivalent to the Coherent UltraPulse 5000 system cleared under K963339 and to the Sharplan SilkTouch/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combination of two products already cleared under K950313 (the laser) and K96… | 1986 |
| * | K960521 | Sharplan Lasers, Inc. Silktouch Flash ScannerSummary page 1…cessory is substantially equivalent to the Coherent UltraPulse 5000 system cleared under K963339 and to the Sharplan SilkTouch/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combination of two products already cleared under K950313 (the laser) and K964684 (the… | 1996 |
| * | K961935 | Sharplan Lasers, Inc. Silktouch CO2 Flash ScannerSummary page 1…bstantially equivalent to the Coherent UltraPulse 5000 system cleared under K963339 and to the Sharplan SilkTouch/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combination of two products already cleared under K950313 (the laser) and K964684 (the scanner), an… | 1996 |
| * | K950313 | Kaplan Pendulaser 115 - a 15W CO2 Surgical LaserSummary page 1…to the Sharplan SilkTouch/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combination of two products already cleared under K950313 (the laser) and K964684 (the scanner), and so the new device can also be considered to be substantially equivalent.in parts to th… | 1995 |
| * | K964684 | SoftouchSummary page 1…h/Sharplan 1020 Laser cleared under K860087, K960521, and K961935. The new device is actually a combination of two products already cleared under K950313 (the laser) and K964684 (the scanner), and so the new device can also be considered to be substantially equivalent.in parts to these two devices. B. DEV… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 15 ancestors has a recall.
- 8 other devices also cite its predicate K963339.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (186 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980398: Kaplan Pendulaser 115 Surgical Laser with Optoscan II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026