Exact device record

InMode System with Morpheus8 Applicators

InMode MD Ltd. · Prescription Class II fractional radiofrequency microneedling device

Trust review pending92
FDA clearance record
Regulatory statusFDA-cleared Class II medical device through the 510(k) substantial-equivalence pathway; not PMA-approvedK231790 · Cleared July 20, 2023
Cleared useDermatologic procedures where coagulation or contraction of soft tissue, or hemostasis, is neededProvider-selected patients; the clearance limits energy above 62 mJ per pin to Fitzpatrick Skin Types I-IV
DeviceFractional RF multi-electrode systemInMode console and RF generator/controller with fractional multi-electrode Morpheus8 applicators and detachable sterilized single-use 12-pin, 24-pin, and T tips; the Body applicator uses a 40-pin tip
Independent trust review · spa-trust-1.0

Trust review pending

No Trusted product badge is issued until every critical gate passes.

92of 10085 required
4/5 gates passedReviewed Jul 18, 2026Valid until Jan 14, 2027
See validation gates and evidence
Exact device identified

The record identifies the InMode System with Morpheus8 Applicators and K231790 rather than a generic RF microneedling category.

Required gate · 1 receipt
pass
Clearance status verified

The record correctly describes Class II 510(k) substantial-equivalence clearance and does not relabel it as PMA approval.

Required gate · 1 receipt
pass
Current FDA safety warning attached

The public record preserves reported burns, scarring, fat loss, disfigurement, nerve damage, and the professional medical-use boundary.

Required gate · 2 receipts
pass
Exact-device periorbital effectiveness

K231790 included no clinical performance data and does not specifically establish under-eye effectiveness. A device-specific clinical evidence receipt has not yet closed this boundary.

Required gate · 1 receipt
pending
Current source review

The clearance and FDA safety sources were reviewed within the active trust window.

Required gate · 3 receipts
pass
Exact device identity99

Manufacturer, device family, applicators, tips, classification, and 510(k) number are explicit.

Regulatory verification98

The FDA 510(k) summary is attached and is described as clearance through substantial equivalence, not PMA approval.

Use-boundary completeness94

The cleared intended use and energy-specific skin-type limit are visible without inventing an under-eye indication.

Device-specific clinical evidence68

K231790 includes bench and ex-vivo evidence but states that no clinical performance data were submitted.

Safety disclosure98

The active FDA warning, serious complications, professional-use boundary, and non-reversibility are preserved.

Source traceability98

Identity, clearance, and safety claims resolve to current FDA receipts.

Evidence receipts

Potential Risks with Certain Uses of Radiofrequency MicroneedlingU.S. Food and Drug Administration · regulator100%Microneedling DevicesU.S. Food and Drug Administration · regulator100%InMode System with Morpheus8 Applicators - K231790U.S. Food and Drug Administration · regulator100%

What this does not mean

  • Trust review remains pending. The exact device does not currently receive a Trusted product badge.
  • Clearance verifies a regulatory pathway and intended-use boundary; it does not establish under-eye effectiveness, superiority, or a patient-specific benefit.
  • 510(k) clearance is based on substantial equivalence. It is not PMA approval and does not prove superiority, patient-specific benefit, or a safe setting for every anatomy.
  • K231790 did not include clinical performance data and does not specifically establish periorbital or under-eye effectiveness.
  • Small periorbital studies in the treatment record cannot be transferred automatically to Morpheus8, another device, another tip, another setting, or another operator.
  • Energy above 62 mJ per pin is limited by the clearance to Fitzpatrick Skin Types I-IV.
  • Device-record trust does not confirm a clinic's current inventory, authentic tip, provider assignment, settings, ocular protection, price, follow-up, outcomes, or emergency process.
  • A Facial Harmony scan or preview cannot select the device, tip, depth, energy, passes, treatment boundary, or candidate.

What is verified

K231790 verifies the exact device family, intended use, technological characteristics, bench testing, electrical safety, biocompatibility, and ex-vivo tissue testing. The submission states that no clinical performance data were included, so clearance alone does not establish under-eye effectiveness or an individualized protocol.

Manufacturer
InMode MD Ltd.
Administration
A licensed, trained clinician selects the exact applicator, sterile single-use tip, treatment boundary, depth, energy, pulse, passes, and protective protocol after an in-person assessment
Access
Prescription Class II medical device for professional medical use; not an at-home treatment

Safety boundary

The FDA warns that certain uses of RF microneedling have been associated with burns, scarring, fat loss, disfigurement, nerve damage, and complications requiring medical or surgical intervention. Risk depends on the exact device, tip, settings, treatment boundary, anatomy, skin tone, provider, and response plan.

Common and expected

  • Transient redness
  • Swelling
  • Tenderness or heat
  • Pinpoint marks or crusting
  • Temporary dryness or sensitivity

Rare but serious

  • Burns
  • Scarring
  • Fat loss or contour change
  • Disfigurement
  • Nerve damage
  • Injury requiring medical or surgical treatment

What does not transfer

  • 510(k) clearance is based on substantial equivalence. It is not PMA approval and does not prove superiority, patient-specific benefit, or a safe setting for every anatomy.
  • K231790 did not include clinical performance data and does not specifically establish periorbital or under-eye effectiveness.
  • Small periorbital studies in the treatment record cannot be transferred automatically to Morpheus8, another device, another tip, another setting, or another operator.
  • Energy above 62 mJ per pin is limited by the clearance to Fitzpatrick Skin Types I-IV.
  • Device-record trust does not confirm a clinic's current inventory, authentic tip, provider assignment, settings, ocular protection, price, follow-up, outcomes, or emergency process.
  • A Facial Harmony scan or preview cannot select the device, tip, depth, energy, passes, treatment boundary, or candidate.

Do not use

  • At home or with a non-medical operator
  • Over active infection, open skin, or unresolved inflammation in the treatment area
  • When the clinic will not identify the exact device, single-use tip, treatment anatomy, or licensed provider
See candidacy, outcomes, care, and alternatives
Source ledger

3 product receipts

Potential Risks with Certain Uses of Radiofrequency MicroneedlingU.S. Food and Drug Administration · Reviewed 2026-07-15Microneedling DevicesU.S. Food and Drug Administration · Reviewed 2026-07-15InMode System with Morpheus8 Applicators - K231790U.S. Food and Drug Administration · Reviewed 2026-07-15