510(k) · Cleared
ClearedAltus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide 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 Oct 8, 2002 as substantially equivalent to K991798 (Altus Medical, 2000) and 13 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1992. 665 later devices descend from it.
- Decided
- Oct 8, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 14
Its longest line of descent runs back 6 generations to K910422 (1992). 77 ancestors in all, the oldest K820106 (1982). 665 later devices descend from it, 11 citing it directly.
- Root · 6 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 4 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 3 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 2 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 1 generation backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- This deviceK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
- Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 227 of its ownK023881 Profile 1064 Laser SystemSciton, Inc · 2003
- Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 665 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 665 · See all- K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · cites it directly519descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
- K023881Profile 1064 Laser SystemSciton, Inc · 2003 · cites it directly227descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −5 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −3 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −2 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −1 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| 0 (this device) | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +1 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
| +2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K023881 | Profile 1064 Laser System | Sciton, Inc | 2003 | — |
| +2 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 0 |
| 2009 | 10 | 0 |
| 2010 | 18 | 0 |
| 2011 | 21 | 0 |
| 2012 | 19 | 0 |
| 2013 | 22 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 36 | 0 |
| 2017 | 31 | 0 |
| 2018 | 29 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 31 | 0 |
| 2022 | 51 | 0 |
| 2023 | 40 | 0 |
| 2024 | 69 | 0 |
| 2025 | 81 | 0 |
| 2026 | 46 | 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…Laser Powered Surgical Instrument (and Accessories) 111. Predicate Devices 0 Family of CoolGlide Aesthetic Lasers, manufactured by Altus Medical (K99 1798, K991234, KO03202 and KO14040); 0 NLite Pulsed Dye Laser, manufactured by ICN (KO0081 1, KO 14130, and KO… | 2000 |
| * | K991234 | The Acme Medical Aesthetic ND:Yag LaserSummary page 1…gical Instrument (and Accessories) 111. Predicate Devices 0 Family of CoolGlide Aesthetic Lasers, manufactured by Altus Medical (K99 1798, K991234, KO03202 and KO14040); 0 NLite Pulsed Dye Laser, manufactured by ICN (KO0081 1, KO 14130, and KO13461); 0 V… | 1999 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II | 2001 |
| * | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 |
| * | K000811 | Nlite System, SLS Model Number A00-1025Summary page 3…ted Altus Medical family of CoolGlide Aesthetic Nd:YAG Lasers (K991798, K991234, KO03202 and KO14040), the m i t e Pulsed Dye Laser, manufactured by ICN (K000811, KO 14130, and KO 13461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (KO 13043 and KO 13748)… | 2000 |
| * | K014130 | Nlite SystemSummary page 4…us Medical family of CoolGlide Aesthetic Nd:YAG Lasers (K991798, K991234, KO03202 and KO14040), the NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (KO13043 and K013748), the PhotoGe… | 2002 |
| * | K013461 | Nlite System,Model A00-1025Summary page 4…mily of CoolGlide Aesthetic Nd:YAG Lasers (K991798, K991234, KO03202 and KO14040), the NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (KO13043 and K013748), the PhotoGenica Pulsed D… | 2002 |
| * | K013043 | Candela Clearbeam Pulsed Dye Laser | 2001 |
| * | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam)Summary page 4…NLite Pulsed Dye Laser, manufactured by ICN (K000811, K014130, and K013461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (KO13043 and K013748), the PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (K012806), the CoolTouch I and CoolTouch II Nd:YAG l… | 2002 |
| * | K012806 | Cynosure Photogenica VLSummary page 4…3461), the Vbeam and Clearbeam Pulsed Dye Lasers, manufactured Candela (KO13043 and K013748), the PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (K012806), the CoolTouch I and CoolTouch II Nd:YAG lasers, manufactured by ICN (KO14035 and K003715), the Smoothbeam Diode… | 2001 |
| * | K014035 | Cooltouch and Cooltouch-II ND:Yag Laser Systems | 2002 |
| * | K003715 | Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch…Summary page 1…PhotoGenica Pulsed Dye Laser, manufactured by Cynosure (KO 12806); CoolTouch I and CoolTouch II Nd:YAG lasers, manufactured by ICN (KO14035 and K003715); and Smoothbeam Diode Laser, manufactured by Candela (KO 13825). Lyra Surgical Laser System, manufactu… | 2001 |
| * | K013825 | Candela Smoothbeam Laser System | 2002 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…K003715); and Smoothbeam Diode Laser, manufactured by Candela (KO 13825). Lyra Surgical Laser System, manufactured by Laserscope (K020021) IV. Product Description Family of Altus Medical CoolGlide Aesthetic Lasers are comprised of the following main… | 2002 |
What descends from it? (665)
See all 66511 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033251 | The Friendlylight ND: Yag Lasers | 2004 | 519 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
| K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of… | 2005 | 200 |
| K032220 | Adept 1064/532 Laser | 2003 | 126 |
| K103626 | Cutera Genesisplus Laser System | 2011 | 121 |
| K032218 | Adept 1064/532/755 Laser | 2003 | 104 |
| K110370 | Q-Clear | 2011 | 35 |
| K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060 | 2014 | 24 |
| K031828 | Naturalase LP ND:Yag Laser | 2003 | 5 |
| K033072 | Lucentlite, Model Imd 010 | 2004 | 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.
- 2 of the 77 ancestors have a recall of any class.
- Of its descendants, K033251 (Innotech USA, Inc., 2004) has gone furthest, with 519 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 Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopicAaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonaryhhoracic surgery and urology for surgical and aesthetic applications. 1064nm: Dermatology: The Altus Medical Aesthetic CoolGlide laser systems are intended for the…
Read the full statement (446 words)
The family of Altus Medical CoolGlide Aesthetic Lasers are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopicAaproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonaryhhoracic surgery and urology for surgical and aesthetic applications.
1064nm:
Dermatology:
The Altus Medical Aesthetic CoolGlide laser systems are intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such 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 CoolGlide lasers are also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (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 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 CoolGlide laser handpiece is to provide cooling of the skin, 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, coagulationhemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy, gastroenterology, general surgery, head and necldotorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, 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; slun 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/K022226 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022226
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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