MedTechIndexBETA
The MedTechIndex Briefing

Keep up with MedTechIndex.

A weekly note from Blair, new companies added to the directory, and meaningful updates to existing profiles.

Confirm your email to join. Email privacy

Companies / R2 Technologies / Glacial Skin
Medical device company profile

R2 Technologies / Glacial Skin

Precision contact-cooling aesthetic systems marketed under the Glacial Skin brand.

Medical Device ManufacturerDermatology & AestheticsDermatologyMedical AestheticsCommercial-stage
HeadquartersπŸ‡ΊπŸ‡ΈUnited States
Founded2014
Commercial statusCommercially availableSelected products commercially offered; availability and indications vary by product and market.
EmployeesNot confirmed
Estimated revenueNot confirmed
Disclosed fundingUS$15 million [11]Series C investment Β· Jul 2021
Official websitewww.glacialskin.com β†—

Company overview

R2 Technologies is the company behind Glacial Skin, a family of aesthetic cooling systems and treatment protocols. Its Cryomodulation approach controls treatment time and temperature to cool skin for device-specific dermatologic uses and aesthetic services.

The company distinguishes Glacial Rx, Glacial fx and related treatment offerings. Reviewed FDA records identify the Dermal Cooling System and its accessories; those authorizations should not be applied indiscriminately to spa protocols, topical products or every branded treatment.

Tim Holt is President and CEO. The company traces its formation to 2014 through Pansend Life Sciences, Blossom Innovations and Massachusetts General Hospital, and describes a strategic relationship with Huadong Medicine. Commercial execution includes provider adoption, training and international collaboration.

[11][13][14][15][16]

Leadership

1 people
Tim HoltPresident & Chief Executive Officer [15]

Products & regulatory status How does MedTechIndex get this information?

Summary

Glacial Rx/Dermal Cooling System has multiple 510(k) decisions, including earlier system and dermabrasion-tip records missing from the prior snapshot. Device labeling for temporary cooling-related effects is distinct from broader cosmetic protocols and Glacial brand marketing. [15][14][12][4][2][16][1]

No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [9][7]

Regulatory snapshot How to read this snapshot

U.S. FDA
4
510(k) clearances
0
De Novo grants
0
PMA approvals
0
Recall events

Latest recorded source review: 2026-10-20.

Commercial portfolio snapshot

Documented commercial product families.

Contact-cooling aesthetic device

Glacial Rx / Dermal Cooling System β†—

Temperature-controlled dermal cooling platform; FDA record identifies device and accessory scope. [14][12]

FDA-cleared

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Aesthetic cooling offerings

Glacial fx and branded cooling protocols β†—

Additional marketed cooling offerings and protocols; exact device-to-authorization mapping remains incomplete. [14]

Marketed Β· regulatory scope varies

Commercially offered; exact model and country availability should be confirmed with the manufacturer.

Commercial development

Commercial Glacial brand portfolio; selected Dermal Cooling System record is not a blanket authorization of every protocol or cosmetic claim. [15][14][12]

16 Cited Sources

Accessed 10/29/2026

[1] FDA 510(k) database β€” research search β†—FDA / openFDA Β· regulatory record
[2] FDA K171398 β€” Dermal Cooling System β†—U.S. Food and Drug Administration Β· regulatory record
[3] FDA K201260 β€” Dermal Cooling System β†—U.S. Food and Drug Administration Β· regulatory record
[4] FDA K203006 β€” R2 Dermabrasion Tip (for Dermal Cooling System) β†—U.S. Food and Drug Administration Β· regulatory record
[5] FDA K213294 β€” Dermal Cooling System β†—U.S. Food and Drug Administration Β· regulatory record
[6] FDA De Novo database β€” research search β†—FDA / openFDA Β· regulatory record
[8] FDA PMA database β€” research search β†—FDA / openFDA Β· regulatory record
[10] FDA UDI database β€” research search β†—FDA / openFDA Β· regulatory record
[12] FDA 510(k) K213294 β†—U.S. Food and Drug Administration Β· regulatory database
[13] 2026 commercial collaborations announcement β†—R2 Technologies Β· company press release
[14] Glacial platform and treatment offerings β†—R2 Technologies / Glacial Skin Β· company website
[15] Company history, leadership and partnerships β†—R2 Technologies / Glacial Skin Β· company website
[16] Employer hiring source reviewed β†—R2 Technologies / Glacial Skin Β· company website
Company research

Compare companies

Privacy choices

Your saved-company and comparison preferences are stored separately. Changing analytics preferences does not clear them.

About cookies and privacy