510(k) · Cleared
ClearedSlim E30 II CO2 Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lasering S.R.L. · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Cleared on Jul 22, 2011 after a 106-day review. The FDA summary names no predicate by number. 23 later devices descend from it.
- Decided
- Jul 22, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- ONG
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK110984 Slim E30 II CO2 LaserLasering S.R.L. · 2011
- Descendant · cites it directly · 19 of its ownK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · 2 generations on · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- Descendant · 3 generations on · 10 of its ownK170325 Secret RFIlooda Co,., Ltd. · 2017
- Descendant · 4 generations on · 3 of its ownK210084 SilkroHironic Co., Ltd. · 2022
- Descendant · 4 generations on · 3 of its ownK180654 PINXEL-RF systemRohrer Aesthetics, LLC · 2018
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K123573Youlaser CO2 LaserQuanta System Spa · 2013 · cites it directly19descendants
- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · 2 generations on14descendants
- K170325Secret RFIlooda Co,., Ltd. · 2017 · 3 generations on10descendants
- K210084SilkroHironic Co., Ltd. · 2022 · 4 generations on3descendants
- K180654PINXEL-RF systemRohrer Aesthetics, LLC · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110984 | Slim E30 II CO2 Laser | Lasering S.R.L. | 2011 | — |
| +1 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +2 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| +3 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
| +4 | K210084 | Silkro | Hironic Co., Ltd. | 2022 | — |
| +4 | K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 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 ONG? 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 ONG device
- #1 K250402 AVAVA™ Skin Treatment Systemscore 19.1 · 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?
The FDA summary names no predicate by number.
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K123573 (Quanta System Spa, 2013) has gone furthest, with 19 descendants of its own.
How does its category compare?
All ONG devicesONG Powered Laser Surgical Instrument With MicrobeamFractional Output: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ONG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONG
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONG
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONG
1in 2025
MAUDE reports naming product code ONG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 4 | 176 | 1 | 3 |
| 2011 | 6 | 122 | 0 | 2 |
| 2012 | 2 | — | 0 | 4 |
| 2013 | 3 | 243 | 0 | 4 |
| 2014 | 2 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 8 |
| 2017 | 1 | — | 0 | 40 |
| 2018 | 2 | — | 0 | 27 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 3 | 203 | 0 | 2 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 1 | — | 2 | 11 |
| 2025 | 4 | 97 | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SLIM Evolution 11 C02 Laser and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures. Laser skin resurfacing Treatment of furrows and wrinkles Removal of skin tags, actinic…
Read the full statement (205 words)
The SLIM Evolution 11 C02 Laser and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Dermatology, Plastic Surgery and General Surgery procedures.
Laser skin resurfacing
Treatment of furrows and wrinkles
Removal of skin tags, actinic keratosis, acne scars, keloids, tattos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty
Site preparation for hair transplants
MiXto fractional scanner only for treatment of wrinkles and skin resurfacing
Dental procedure including.
Periodontal procedures such as - gingivectomy, removal of hyperplasias,gingivoplasty (incision and excision)
Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis
Podiatry procedures.
Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixeetorny and verrucae vulgares.
Otorhinolaryngology (ENT) procedures.
Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomnatosis polyps.
Gynecology
Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia.
Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimnbroplasty,
Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110984 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110984: Slim E30 II CO2 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110984
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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