510(k) · Cleared
ClearedMultipulse CO2 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap-Meditec GmbH · GEX Powered Laser Surgical Instrument
Cleared on Dec 4, 1998 after an 81-day review. The FDA summary names its predicate without a number. 377 later devices descend from it.
- Decided
- Dec 4, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
377 later devices descend from it, 1 citing it directly.
- This deviceK983215 Multipulse CO2 LaserAesculap-Meditec GmbH · 1998
- Descendant · cites it directly · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- Descendant · 2 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- Descendant · 2 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
- Descendant · 2 generations on · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
Showing 5 of 377 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 377 · See all- K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · cites it directly376descendants
- K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 2 generations on323descendants
- K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 2 generations on318descendants
- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · 2 generations on316descendants
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983215 | Multipulse CO2 Laser | Aesculap-Meditec GmbH | 1998 | — |
| +1 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| +2 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| +2 | K031795 | Reliant Laser System | Reliant Technologies, Inc. | 2003 | — |
| +2 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +2 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 9 | 0 |
| 2008 | 13 | 0 |
| 2009 | 7 | 0 |
| 2010 | 7 | 0 |
| 2011 | 13 | 0 |
| 2012 | 8 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 12 | 0 |
| 2018 | 22 | 0 |
| 2019 | 10 | 0 |
| 2020 | 28 | 0 |
| 2021 | 19 | 0 |
| 2022 | 36 | 0 |
| 2023 | 25 | 0 |
| 2024 | 41 | 0 |
| 2025 | 41 | 0 |
| 2026 | 26 | 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? (1)
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 |
|---|---|---|---|
| * | — | M.L.T. 30 Named without a submission number |
What descends from it? (377)
See all 3771 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories | 2002 | 376 |
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?
- Of its descendants, K022060 (Lumenis, Inc., 2002) has gone furthest, with 376 descendants of its own.
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 Aesculap-Meditec CO, laser is intended for the ablation, vaporization, inciston, excision, and or cutting of soff tissue in: Oral surgery Dermatology Examples: Removal of smalt skin tumors, superficial pigmented lesions, adeno-sebaceous hypertrophy, treatment of scars, skin tags, etc. Skin resurfacing (scanning mode) Blepharoplasty EN.T. Examples: Tumor surgery of the larynx and pharynx LAUP Stenosis CAUTION: Patients should be diagnosed with tissue…
Read the full statement (109 words)
The Aesculap-Meditec CO, laser is intended for the ablation, vaporization, inciston, excision, and or cutting of soff tissue in:
Oral surgery
Dermatology
Examples: Removal of smalt skin tumors, superficial pigmented lesions, adeno-sebaceous hypertrophy, treatment of scars, skin tags, etc.
Skin resurfacing (scanning mode)
Blepharoplasty
EN.T.
Examples: Tumor surgery of the larynx and pharynx
LAUP
Stenosis
CAUTION: Patients should be diagnosed with tissue problems to exclude those whose problems are caused by being overweight or to drinking problems.
Remind patients that there may be vocalization problems after laser surgery.
Gynaecology
The examples are not intended to be exhaustive or complete but to serve as a general guide to the surgeon.
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/K983215 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983215: Multipulse CO2 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983215
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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