510(k) · Cleared
ClearedThe Acme Medical Aesthetic ND:Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acme Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 28, 1999 as substantially equivalent to K980537 (Esc Medical Systems, Ltd., 1998) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1998. 755 later devices descend from it.
- Decided
- Jun 28, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K980537 (1998). 2 ancestors in all. 755 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK980537 ND: Yag Accessory for Photoderm SystemEsc Medical Systems, Ltd. · 1998
- This deviceK991234 The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999
- Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 700 of its ownK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- Descendant · 2 generations on · 699 of its ownK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
- Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
Showing 5 of 755 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 755 · See all- K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
- K993671Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000 · cites it directly700descendants
- K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002 · 2 generations on699descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
- K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 2 generations on656descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980537 | ND: Yag Accessory for Photoderm System | Esc Medical Systems, Ltd. | 1998 | — |
| 0 (this device) | K991234 | The Acme Medical Aesthetic ND:Yag Laser | Acme Medical, Inc. | 1999 | — |
| +1 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| +1 | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| +2 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| +1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +2 | K022923 | Candela Gentle Yag Laser System | Candela Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 16 | 0 |
| 2008 | 28 | 0 |
| 2009 | 16 | 0 |
| 2010 | 19 | 0 |
| 2011 | 25 | 0 |
| 2012 | 22 | 0 |
| 2013 | 30 | 0 |
| 2014 | 32 | 0 |
| 2015 | 27 | 0 |
| 2016 | 40 | 0 |
| 2017 | 33 | 0 |
| 2018 | 34 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 55 | 0 |
| 2023 | 43 | 0 |
| 2024 | 71 | 0 |
| 2025 | 84 | 0 |
| 2026 | 47 | 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? (2)
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 |
|---|---|---|---|
| * | K980537 | ND: Yag Accessory for Photoderm SystemSummary page 1…for use, and treatment parameters of the Acme Medical Aesthetic Nd:YAG Laser are the same or very similar to the following legally marketed lasers: ¢ ESC Vasculight DL (K980537) + HMG VeinLase (K981952) Product Description The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared l… | 1998 |
| * | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green LaserSummary page 1…ameters of the Acme Medical Aesthetic Nd:YAG Laser are the same or very similar to the following legally marketed lasers: ¢ ESC Vasculight DL (K980537) + HMG VeinLase (K981952) Product Description The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. Itis intended to del… | 1998 |
What descends from it? (755)
See all 7554 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K993671 | Candela Sclero Long Pulse Dye Laser | 2000 | 700 |
| K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future… | 2002 | 665 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
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?
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?
For coagulation and hemostasis of vascular lesions.
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/K991234 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991234: The Acme Medical Aesthetic ND:Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991234
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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