510(k) · Cleared
ClearedAltus Medical Coolglide Laser Systems and Accessories
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 Mar 18, 2003 as substantially equivalent to K013365 (Medical Bio Care Sweden AB, 2002) and 13 other predicates after a 111-day review. Its family tree reaches back 6 generations to 1992. 1,117 later devices descend from it.
- Decided
- Mar 18, 2003
- Review
- 111 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 6 generations to K910422 (1992). 28 ancestors in all, the oldest K892514 (1990). 1,117 later devices descend from it, 19 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 backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 1 generation backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- This deviceK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- Descendant · cites it directly · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- Descendant · cites it directly · 569 of its ownK032460 Profile BBL SystemSciton, Inc · 2003
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Showing 5 of 1,117 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,117 · See all- K033946Lovely SystemMsq (M2), Ltd. · 2004 · cites it directly737descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · cites it directly678descendants
- K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · cites it directly654descendants
- K032460Profile BBL SystemSciton, Inc · 2003 · cites it directly569descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
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 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −1 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| 0 (this device) | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| +1 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +1 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +1 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| +1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 12 | 0 |
| 2006 | 17 | 0 |
| 2007 | 25 | 0 |
| 2008 | 40 | 0 |
| 2009 | 33 | 0 |
| 2010 | 27 | 0 |
| 2011 | 32 | 0 |
| 2012 | 28 | 0 |
| 2013 | 46 | 0 |
| 2014 | 46 | 0 |
| 2015 | 38 | 0 |
| 2016 | 56 | 0 |
| 2017 | 51 | 0 |
| 2018 | 46 | 0 |
| 2019 | 41 | 0 |
| 2020 | 56 | 0 |
| 2021 | 55 | 0 |
| 2022 | 77 | 0 |
| 2023 | 71 | 0 |
| 2024 | 98 | 0 |
| 2025 | 130 | 0 |
| 2026 | 77 | 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? (16)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013365 | Prolite Pulsed Light System for the Treatment of Pigmented Lesions and the Removal of… | 2002 |
| Kept off the family tree | K012130 | FDA’s K012130 is Attain LDS 6216 Left-Heart Delivery System Our reading of the summary gave K012130, FDA’s number for Attain LDS 6216 Left-Heart Delivery System (Medtronic Vascular). Its FDA name has none of the distinctive words the summary uses for the device it names, “Prolite/Plasmalite”. Kept off the family tree. | 2001 |
| * | K000929 | Prolite Pulsed Light SystemSummary page 1…alite manufactured by Medical Bio Care AB of Sweden (KO13365 and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lum… | 2000 |
| * | K002072 | Prolite VL Pulsed Light SystemSummary page 1…actured by Medical Bio Care AB of Sweden (KO13365 and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Is… | 2000 |
| * | K010927 | Modification to Prolite Pulsed Light SystemSummary page 1…by Medical Bio Care AB of Sweden (KO13365 and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K96… | 2001 |
| * | K010928 | Prolite VL Pulsed Light SystemSummary page 1…l Bio Care AB of Sweden (KO13365 and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K960772… | 2001 |
| * | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | 2002 |
| * | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted HairSummary page 1…eden (KO13365 and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K960772 for benign… | 2002 |
| * | K022569 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Vascular LesionsSummary page 1…and KO 121304 for benign pigmented lesions; other clearances for this device include K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K960772 for benign pigmented les… | 2002 |
| * | K960772 | Photoderm PL.Summary page 1…lude K000929, K0002072, K010927, K010928, KO1 3366, K022568, and K022569); Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K960772 for benign pigmented lesions; other clearances for this device include K963249, K'374536, K991935, K99401… | 1996 |
| * | K963249 | Epilight Hair Removal SystemSummary page 1…Photoderm/Epilight/QuantumNasculightmanufactured by Lumenis of Israel (K960772 for benign pigmented lesions; other clearances for this device include K963249, K'374536, K991935, K994014); and Estelux manufactured by Palomar (K20453 and KO20941 for benign pigmente… | 1997 |
| * | K974536 | Photoderm HR System Our reading of the summary gave K374536, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 1998 |
| * | K991935 | Epilight Hair Removal System, Photoderm HR SystemSummary page 1…tumNasculightmanufactured by Lumenis of Israel (K960772 for benign pigmented lesions; other clearances for this device include K963249, K'374536, K991935, K994014); and Estelux manufactured by Palomar (K20453 and KO20941 for benign pigmented lesions). IV. Produc… | 2000 |
| * | K994014 | Esc Intense Pulsed Light Systems: Epilight and MultilightSummary page 1…ightmanufactured by Lumenis of Israel (K960772 for benign pigmented lesions; other clearances for this device include K963249, K'374536, K991935, K994014); and Estelux manufactured by Palomar (K20453 and KO20941 for benign pigmented lesions). IV. Product Descrip… | 2000 |
| Kept off the family tree | K020453 | FDA’s K020453 is Palomar Estelux Pulsed Light System and Palomar Coolroller Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2002 |
| * | K020941 | Palomar Luxg Handpiece | 2002 |
What descends from it? (1,117)
See all 1,11719 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033946 | Lovely System | 2004 | 737 |
| K031671 | Polaris WR | 2003 | 678 |
| K033172 | Candela Gentleyag Family of Laser Systems | 2003 | 654 |
| K032460 | Profile BBL System | 2003 | 569 |
| K042000 | Modified MSQ Family of Lovely Light/Laser Systems | 2004 | 517 |
| K040617 | Reliant Laser System II | 2004 | 316 |
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K042165 | Cutera Tabletop Aesthetic Product | 2004 | 241 |
| K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of… | 2005 | 200 |
| K070388 | Profile Multi-Platform System | 2007 | 129 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K033946 (Msq (M2), Ltd., 2004) has gone furthest, with 737 descendants of its own.
- 3 other devices also cite its predicate K013365.
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 with Optional Pulsed Light Hand Piece: 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…
Read the full statement (484 words)
The family of Altus Medical CoolGlide Aesthetic Lasers with Optional Pulsed Light Hand Piece: 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 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, keraioses, 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 the 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 optional pulsed light hand piece is indicated for the treatment of benign pigmented lesions.
The intended use of the integral cooling system in the Altus 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.
Optional Pulsed Light Hand Piece:
For the treatment of benign pigmented lesions.
Surgical Applications:
The lasers are indicated for the incisiodexcision and cutting, ablation, coagulationhemostatis 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/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
532nm:
For c.oagulation 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, cafe-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/K023954 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023954: Altus Medical Coolglide Laser Systems and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023954
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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