510(k) · Cleared
ClearedFamily of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 3, 2002 as substantially equivalent to K991798 (Altus Medical, 2000) and 13 other predicates after a 178-day review. Its family tree reaches back 5 generations to 1992. 739 later devices descend from it.
- Decided
- Jun 3, 2002
- Review
- 178 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 5 generations to K910422 (1992). 35 ancestors in all, the oldest K892514 (1990). 739 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 4 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 3 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 2 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 1 generation backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- This deviceK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
- Descendant · cites it directly · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- Descendant · 2 generations on · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- Descendant · 2 generations on · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Showing 5 of 739 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 739 · See all- 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 · cites it directly656descendants
- K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · cites it directly656descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · 2 generations on654descendants
- K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 2 generations on519descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −4 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −3 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −2 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −1 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| 0 (this device) | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| +1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +1 | K022923 | Candela Gentle Yag Laser System | Candela Corp. | 2003 | — |
| +1 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| +2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| +2 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 26 | 0 |
| 2009 | 16 | 0 |
| 2010 | 19 | 0 |
| 2011 | 25 | 0 |
| 2012 | 22 | 0 |
| 2013 | 29 | 0 |
| 2014 | 32 | 0 |
| 2015 | 27 | 0 |
| 2016 | 39 | 0 |
| 2017 | 33 | 0 |
| 2018 | 33 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 54 | 0 |
| 2023 | 42 | 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? (14)
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 |
|---|---|---|---|
| * | K991798 | Acme Medical Aesthetic ND:Yag LaserSummary page 1…imary Classification Name: Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices Altus Medical Aesthetic Nd:YAG Laser (K991798, K991234 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by… | 2000 |
| * | K991234 | The Acme Medical Aesthetic ND:Yag LaserSummary page 1…ssification Name: Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices Altus Medical Aesthetic Nd:YAG Laser (K991798, K991234 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by ESC Medi… | 1999 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & IISummary page 1…Name: Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices Altus Medical Aesthetic Nd:YAG Laser (K991798, K991234 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by ESC Medical Systems… | 2001 |
| * | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green LaserSummary page 1…Accessories) 111. Predicate Devices Altus Medical Aesthetic Nd:YAG Laser (K991798, K991234 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by ESC Medical Systems (K991935 and K980537); Lights… | 1998 |
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…YAG Laser (K991798, K991234 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by ESC Medical Systems (K991935 and K980537); Lightsheer Pulsed Diode Array Laser System, manufactured by Star/Coherent Me… | 2000 |
| * | K980537 | ND: Yag Accessory for Photoderm SystemSummary page 1…34 and K003202); VeinLase, manufactured by HGM (K98 1952); EpiLight PhotoDenn HR, manufactured by ESC Medical Systems (K991935 and K980537); Lightsheer Pulsed Diode Array Laser System, manufactured by Star/Coherent Medical o(982940);… | 1998 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 3…erm HR, manufactured by ESC Medical Systems (K991935 and K980537), the Lightsheer Pulsed Diode Array Laser System, manufactured by Star/Coherent Medical (K982940), the Lyra and Orion/SL/Lyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K9… | 1999 |
| * | K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…ufactured by Star/Coherent Medical o(982940); Lyra and OriodSWLyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03 147 and K003765); and Candela Long Pulse Nd:YAG Laser System, manufactured by Cande… | 2000 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…by Star/Coherent Medical o(982940); Lyra and OriodSWLyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03 147 and K003765); and Candela Long Pulse Nd:YAG Laser System, manufactured by Candela (KO 10… | 1999 |
| * | K941841 | SmartscanSummary page 1…Coherent Medical o(982940); Lyra and OriodSWLyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03 147 and K003765); and Candela Long Pulse Nd:YAG Laser System, manufactured by Candela (KO 10104). I… | 1994 |
| * | K933880 | SL Series Surgical Laser SystemsSummary page 1…Medical o(982940); Lyra and OriodSWLyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03 147 and K003765); and Candela Long Pulse Nd:YAG Laser System, manufactured by Candela (KO 10104). IV. Pr… | 1994 |
| * | K003147 | Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration) | 2000 |
| * | K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…(982940); Lyra and OriodSWLyra Series Laser Systems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03 147 and K003765); and Candela Long Pulse Nd:YAG Laser System, manufactured by Candela (KO 10104). IV. Product Description… | 2001 |
| * | K010104 | Candela Long Pulse ND:YagSummary page 3…stems and Smartscan, manufactured by Laserscope (K990718, K990903, K941841, K933880, KO03147 and K003765) and the Candela Long Pulse Nd:YAG Laser System (K010104). The family of Altus Medical Modified CoolGlide Aesthetic Lasers share similar indications for use, design featu… | 2001 |
What descends from it? (739)
See all 7399 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future… | 2002 | 665 |
| K022923 | Candela Gentle Yag Laser System | 2003 | 656 |
| K023193 | Candela Gentle Yag Laser System | 2002 | 656 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
| K032220 | Adept 1064/532 Laser | 2003 | 126 |
| K032218 | Adept 1064/532/755 Laser | 2003 | 104 |
| K031828 | Naturalase LP ND:Yag Laser | 2003 | 5 |
| K161503 | ORION | 2016 | 1 |
| K032221 | Adept 1064/755 Laser | 2003 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 35 ancestors has a recall of any class.
- Of its descendants, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
- 9 other devices also cite its predicate K991798.
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 family of Modified Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. 1064nm: Dermatology: The Altus Medical Aesthetic Modified CoolGlide laser systems…
Read the full statement (416 words)
The family of Modified Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic Modified CoolGlide laser systems are intended for the coaguiation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented €esionssuch as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafk au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blueblack tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The Modified CoolGlide lasers are also indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitisbarbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The Modified CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the Altus Modified CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications::
The lasers are indicated for the incisiodexcision and cutting, ablation, coagulatiodhemostatis of soft tissue in the performance of surgical applications in endosopy/laproscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracicsurgery, gynecology (e.g. menorrhagia) and urology.
532nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions [angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014040
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026